| Coverage Policy Manual | |
| Policy #: | 1998068 |
| Category: | Radiology |
| Initiated: | February 1998 |
| Last Review: | July 2023 |
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| Scintimammography and Gamma Imaging of the Breast and Axilla | |
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| Description: |
Scintimammography refers to the use of radiotracers with nuclear medicine imaging as a diagnostic tool for abnormalities of the breast. Breast-specific gamma imaging (BSGI), or molecular breast imaging (MBI), refer to specific types of imaging machines that are used in conjunction with scintimammography in order to improve diagnostic performance.
Scintimammography is a diagnostic modality using radiopharmaceuticals to detect tumors of the breast. After injection of a radiopharmaceutical, the breast is evaluated with planar imaging. Scintimammography is performed with the patient lying prone and the camera positioned laterally, which increases the distance between the breast and the camera. Scintimammography using conventional imaging modalities has relatively poor sensitivity in detecting smaller lesions (e.g., smaller than 15 mm), because of the relatively poor resolution of conventional gamma cameras in imaging the breast. Breast-specific gamma imaging (BSGI) and molecular breast imaging (MBI) were developed to address this issue. Breast-specific gamma cameras acquire images while the patient is seated in a position similar to that in mammography, and the breast is lightly compressed. The detector head(s) is immediately next to the breast, increasing resolution, and the images can be compared with the mammographic images. Breast-specific gamma imaging and molecular breast imaging differ primarily in the type and number of detectors used (multi-crystal arrays of cesium iodide or sodium iodide versus semiconductor materials, such as cadmium zinc telluride, respectively). In some configurations, a detector is placed on each side of the breast and used to lightly compress it. The maximum distance between the detector and the breast is therefore from the surface to the midpoint of the breast. Much of the research on BSGI and MBI has been conducted at the Mayo Clinic. The radiotracer usually utilized is technetium Tc99m sestamibi. MBI imaging takes approximately 40 minutes (O’Connor, 2009).
Preoperative lymphoscintigraphy and/or intraoperative hand-held gamma detection of sentinel lymph nodes is a method of identifying sentinel lymph nodes for a biopsy after radiotracer injection. Surgical removal of one or more sentinel lymph nodes is an alternative to full axillary lymph node dissection for staging evaluation and management of breast cancer. Several trials have compared outcomes following sentinel lymph node biopsy with axillary lymph node dissection for managing patients who have breast cancer. The National Surgical Adjuvant Breast and Bowel Project trial B-32 examined whether sentinel lymph node dissection provides similar survival and regional control as full axillary lymph node dissection in the surgical staging and management of patients with clinically invasive breast cancer. This multicenter randomized controlled trial included 5,611 women and observed statistically similar results for overall survival, disease-free survival, and regional control based on 8-year Kaplan-Meier estimates (Krag, 2010). An additional 3 -year follow-up of morbidity after surgical node dissection revealed lower morbidity in the sentinel lymph node dissection group, including lower rates of arm swelling, numbness, tingling, and fewer early shoulder abduction deficits (Ashikaga, 2010). A recent systematic review and meta-analysis by Ram et al reported no significant difference in overall survival (hazard ratio, 0.94; 95% confidence interval, 0.79 to1.19), no significant difference in disease-free survival (hazard ratio, 0.83; 95% confidence interval, 0.60 to 1.14), and similar rates of locoregional recurrence (Ram, 2014). However, axillary node dissection was associated with significantly greater surgical morbidity (eg, wound infection, arm swelling, motor neuropathy, numbness) than sentinel node biopsy.
The primary radiopharmaceutical used with BSGI or MBI is technetium Tc99m sestamibi (marketed by Draxis Specialty Pharmaceuticals Inc.; Cardinal Health 414, Dublin, Ohio; LLC, Mallinckrodt Inc., and Pharmalucence, Inc., Bedford, MA). The labeling states that technetium-99m sestamibi is “indicated for planar imaging as a second-line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Technetium Tc99m sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.”
Technetium TC-99m tetrofosmin (Myoview™), a gamma-emitter used in some BSGI studies,(Hruska, 2013; Schillaci, 2013) is U.S. Food and Drug Administration (FDA)-approved only for cardiac imaging (GE Healthcare, 2011).
The primary radiopharmaceuticals used for lymphoscintigraphy include Tc 99m pertechnetate-labeled colloids and Tc 99m tilmanocept (Lymphoseek) (Aarsvold, 2005). Whereas, Tc 99m sulfur colloid may frequently be used for intraoperative injection and detection of sentinel lymph nodes using hand-held gamma detection probe.
The radiation dose associated with BSGI is substantial for diagnostic breast imaging modalities. According to Appropriateness Criteria from the American College of Radiology, the radiation dose from BSGI is 10 to 30 mSv, which is 15 to 30 times higher than the dose from a digital mammogram (ACR, 2017). According to the American College of Radiology, at these levels, BSGI is not indicated for breast cancer screening.
According to a study by Hruska and O’Connor, the effective dose from a lower "off-label" administered dose of 240 to 300 MBq (6.5-8 mCi) of Tc 99m sestamibi that is made feasible with newer dual-head MBI systems, is 2.0 to 2.5 mSv. For comparison, the effective dose (ie, mean glandular dose) of digital mammography is estimated to be about 0.5 mSv (Hruska, 2015). However, it is important to note that the dose for MBI is given to the entire body. The authors compared this dose with the estimated annual background radiation, which varies worldwide between 2.5 mSv and 10 mSv, and asserted that the effective dose from MBI "is considered safe for use in routine screening."
Another article published online in August 2010 calculated mean glandular doses, and from those, lifetime attributable risk of cancer (LAR) for film mammography, digital mammography, BSGI, and positron emission mammography (PEM) (Hendrick, 2010). The author, who is a consultant to GE Healthcare and a member of the medical advisory boards of Koning (which are working on dedicated breast computed tomography [CT]) and Bracco (MR contrast agents), used BEIR VII Group risk estimates (“Health Risks”, 2006) to gauge the risks of radiation-induced cancer incidence and mortality from breast imaging studies. The estimated lifetime attributable risk of cancer for a patient with the average-sized compressed breast during mammography of 5.3 cm (it would be higher for larger breasts) for a single breast procedure at age 40 is
The corresponding lifetime attributable risk of cancer mortality at age 40 is
A major difference in the impact of radiation between mammography and BSGI or PEM is that for mammography, the substantial radiation dose is limited to the breast. With BSGI and PEM, all organs are irradiated, increasing the risks associated with radiation exposure.
Although the use of BSGI (or MBI) has been proposed for women at high-risk of breast cancer, there is controversy and speculation over whether some women (eg, those with BRCAvariants) have a heightened radiosensitivity (Berrington de Gonzalez, 2009; Ernestos, 2010). If women with BRCA variants are more radiosensitive than the general population, studies may underestimate the risks of breast imaging with ionizing radiation (ie, mammography, BSGI, MBI, positron emission mammography, single-photon emission computed tomography/computed tomography, breast-specific computed tomography, tomosynthesis) in these women. In contrast, ultrasonography and MRI do not use radiation. More research is needed to resolve this issue. Also, the risk associated with radiation exposure will be greater for women at high-risk of breast cancer, whether or not they are more radiosensitive because they start screening at a younger age when the risks associated with radiation exposure are greater. In addition, a large, high-quality, head-to-head comparison of BSGI (or MBI) and MRI would be needed, especially for women at high-risk of breast cancer, because MRI, alternated with mammography, is currently the recommended screening technique.
NOTES:
The term “molecular breast imaging” is used in different ways, sometimes for any type of breast imaging involving molecular imaging, including positron emission mammography (PEM), and sometimes limited to imaging with a type of breast-specific gamma camera, as is used in this report.
Use of single positron emission computed tomography (SPECT) and positron emission tomography (PET) of the breast are not handled in this policy.
Regulatory Status:
Several scintillation (gamma) cameras have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for “measuring and imaging the distribution of radionuclides in the human body by means of photon detection” (FDA, 2000). Examples of gamma cameras used in BSGI are the Dilon 6800® (Dilon Technologies) and single-head configurations of Discovery NM750b (GE Healthcare). Dual-head cameras used in MBI include LumaGEM™ (Gamma Medical) (FDA product code IYX) and Discovery NM750b (GE Healthcare).
Tc-99m sestamibi (Sun Pharmaceutical Industries, Lantheus Medical Imaging, Cardinal Health 414, AnazaoHealth, Curium US, Jubilant Draximage) has been approved by the FDA with the following labeling: "Breast Imaging: Technetium TC 99M Sestamibi is indicated for planar imaging as a second-line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Technetium TC 99M Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy."
In 2013, Tc-99m-tilmanocept (Lymphoseek; Cardinal Health) was approved by the FDA for use in breast cancer and melanoma as a radioactive diagnostic imaging agent that may help to localize lymph nodes.
Technetium-99m-sulfur colloid was approved by the FDA through the new drug application (NDA; GE Healthcare, NDA 017456; Mallinckrodt, NDA 017724) process although these products appear to no longer be marketed. In addition, in 2011, Technetium Tc 99m Sulfur Colloid Kit (Sun Pharmaceutical Industries) was approved by the FDA through the NDA process (NDA 017858) for use as an injection to localize lymph nodes in breast cancer patients.
In 2018, the FDA granted approval to Northstar Medical Radioisotopes for its RadioGenix™ System, which produces molybdenum 99, the material used to generate Tc 99m. Previously, molybdenum 99 was only produced from enriched uranium in facilities outside of the United States.
Coding
A9500: Technetium Tc-99m sestamibi, diagnostic, per study dose, up to 40 millicuries.
The most commonly used radiopharmaceuticals for sentinel lymph node detection using either lymphoscintigraphy or hand-held gamma detection include Tc-99m-labelled colloids such as sulfur colloid.
The HCPCS code for this particular radiopharmaceutical is:
A9541: Technetium Tc-99m sulfur colloid, diagnostic, per study dose, up to 5 millicuries
Among the other possible radiopharmaceuticals is lymphoseek® which is reported with the following
HCPCS code:
A9520: Technetium Tc-99m tilmanocept, diagnostic, up to 0.5 millicuries
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Policy/ Coverage: |
Effective July 2021
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Scintigraphy with technetium Tc-99 sestamibi or any other radiopharmaceutical for the evaluation of breast abnormalities in patients with palpable breast lesions or an abnormal mammogram does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, scintigraphy with technetium Tc-99 sestamibi or any other radiopharmaceutical for the evaluation of breast abnormalities in patients with palpable breast lesions or an abnormal mammogram is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to Effective July 2021
Scintigraphy with technetium Tc-99 sestamibi or any other radiopharmaceutical for the evaluation of breast abnormalities in patients with palpable breast lesions or an abnormal mammogram is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For contracts without primary coverage criteria, scintigraphy with technetium Tc-99 sestamibi or any other radiopharmaceutical for the evaluation of breast abnormalities in patients with palpable breast lesions or an abnormal mammogram is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
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| Rationale: |
This policy was originally developed in 1998 to address scintimammography imaging with Technetium Tc99 Sestamibi (Miraluma). The policy has been redesigned in 2013 to address Scintimammography, Breast-Specific Gamma Imaging (BSGI) and Molecular Breast Imaging (MBI).
An early step in evaluating a new imaging modality for patients who may have breast cancer is to determine whether the modality can detect breast cancer or related diagnoses in women known to have the disease. However, studies of diagnostic performance in this population may be affected by disease spectrum (spectrum effect), among other possible issues. Showing that the modality can detect breast cancer, particularly smaller lesions and types that are more difficult to detect, is important, but not sufficient to demonstrate the true diagnostic performance of a test, which may vary with tumor size, characteristics, etc. These available studies are limited by the retrospective nature of most; by small sample sizes; and by patient populations with mixed indications for imaging (e.g., (Brem, 2007), (Brem, 2009), (Kim, 2012), (Keto, 2012).
Regarding the use of scintimammography to detect axillary metastases, a review of published studies between 1994 and 1998 (Taillefer, 1999) showed a sensitivity of 77% and specificity of 89%. More recent studies using different radiopharmaceuticals have shown sensitivities in the high 80–90% range. (Schillaci, 2002, Spanu, 2001) A meta-analysis published in 2011 (1Xu, 2011) reviewed 45 studies of scintimammography and also reported sensitivities and sensitivities in this range, with summary estimates for sensitivity of 83% (95% confidence interval [CI] 82%-84%) and for specificity of 85% (95% CI 83-86%). The test is still not accurate enough to replace surgical nodal dissection. No studies have examined patient outcomes comparing the strategy of using scintimammography to aid in decision making regarding nodal dissection versus standard nodal dissection. Scintimammography with conventional SPECT imaging, therefore, will not be discussed further in this policy.
A few studies have reported on change in patient management following imaging, but there are insufficient data to determine whether these changes led to improvement in health outcomes (e.g., (Killelea, 2009).
BSGI for Women with Breast Cancer Risk Factors and/or Normal Mammograms
Several prospective studies addressed the performance of BSGI in women at high risk for breast cancer and/or with normal mammograms. Rhodes (Rhodes, 2011) compared the performance of BSGI, mammography, and the combination of the two modalities in 936 asymptomatic women with heterogeneously or extremely dense breasts on prior mammogram as well as additional risk factors. Of 936 women, 11 had cancer. The sample included women with dense breasts and other cancer risk factors, including both women with BRCA mutations and those with a personal history of breast cancer. The risk in these different populations of women varies substantially. Overall sensitivity was 82% (95% CI: 52.3% to 94.9%) for BSGI, 27% (95% CI: 9.7% to 56.6%) for mammography, and 91% (95% CI: 62.3% to 98.4%) for both combined. Specificity was 93% (95% CI: 91.3% to 94.5%) for BSGI, 91% (95% CI: 88.8% to 92.5%) for mammography, and 85% (95% CI: 82.8% to 87.3%) for both (sensitivity and specificity for BSGI versus mammography, both p=0.07). The number of breast cancers diagnosed per number of biopsies performed was 28% for BSGI and 18% for mammography.
Brem (Brem, 2005) used a breast-specific gamma camera to evaluate 94 women considered at high risk of breast cancer despite normal mammographic findings. High risk was defined as a calculated 5-year risk of developing breast cancer of 1.66%, as determined by the Gail model. Of the 94 women in the study, 35 had a prior history of some type of breast cancer or atypical hyperplasia. A total of 16 of the 94 women (17%) had abnormal scintimammograms. Follow-up US in 11 of these 16 identified a hypoechoic lesion that was biopsied. The five remaining patients had normal US results and were followed up with a repeat scintimammogram at six months, which was normal. Of the 11 who underwent US-guided biopsy, two invasive cancers (12%) were identified. The sensitivity of BSGI was 100% (95% CI: 22% to 100%) and the specificity, 85%. The study is limited by the extremely small number of cancers detected.
While the use of BSGI or MBI has been proposed for women at high risk of breast cancer, there is controversy and speculation over whether some women, such as those with BRCA mutations, have a heightened radiosensitivity (Berrington, 2009; Ernestos, 2010). If women with BRCA mutations are more radiosensitive than the population as a whole, the above estimates may underestimate the risks they face from breast imaging with ionizing radiation (i.e., mammography, BSGI, MBI, PEM, SPECT/CT, breast-specific CT, and tomosynthesis) In contrast, ultrasound and MRI do not involve the use of radiation. More research will be needed to resolve this issue. Also, the risk associated with radiation exposure will be greater for women at high risk of breast cancer, whether or not they are more radiosensitive, because they start screening at a younger age when the risks associated with radiation exposure are larger.
Conclusion: There is scant evidence on the use of BSGI in screening women at elevated risk of breast cancer or in women with factors that limit the sensitivity of mammography. Furthermore, the relatively high radiation dose currently associated with BSGI has prompted the American College of Radiology to recommend against the use of BSGI for screening. Therefore, consideration of the potential use of BSGI for screening women with dense breasts or at high risk of breast cancer should await the development of a lower dose regimen, and if warranted, larger, higher quality studies with study populations representative of those encountered in clinical practice. In addition, a large, high quality head-to-head comparison of BSGI and MRI would be needed, especially for women at high risk of breast cancer, since MRI, alternated with mammography, is currently the recommended screening technique.
BSGI for Women with Indeterminate or Suspicious Lesions
A number of prospective studies address the performance of BSGI in women with indeterminate or suspicious lesions. Spanu (Spanu, 2012) assessed the clinical impact of BSGI in a prospective study of 467 women with suspicious lesions on physical examination, MRI, US, or mammogram. Histopathology reports were obtained in all cases. BSGI results were true positive in 408/420 (sensitivity = 97.1%) breast cancer patients, including the detection of multifocal, multicentric disease or bilateral disease, and were false negative in 12 breast cancer patients. BSGI results were true negative in 40/47 (specificity = 85.1%) patients with benign lesions. The authors calculated that BSGI provided additional value compared to mammography in 141/467 (30.2%) patients: 108 with breast cancer and 33 with benign lesions.
Another study by Spanu (Spanu, 2009) evaluated the performance of BSGI compared to single photon emission computed tomography (SPECT) in 157 women with suspicious breast lesions at clinical examination and/or mammography or US. Histopathologic reports were obtained in all cases. Outcomes were calculated on a per lesion basis. Sensitivity was significantly higher for BSGI compared to SPECT (95.7% vs. 90.7%, p<0.01), as was diagnostic accuracy (94.2% vs. 90.2%, p<0.01). Specificity was identical for both imaging modalities (87.9%). In a similar, earlier study by Spanu, (37) BSGI performance was compared to SPECT in 85 patients scheduled to undergo biopsies. Histopathologic findings were obtained in all cases. On a per lesion basis (90 malignant, 12 benign), BSGI sensitivity (96.7%) and accuracy (96.1%) were higher compared to SPECT (92.2% and 92.1% respectively), but the differences were not significantly different. Specificity was identical for both imaging modalities (91.7%).
In a study by Hruska, (24) 150 patients with BI-RADS classification 4 or 5 lesions smaller than 2 cm identified on mammography or US who were scheduled for biopsy underwent scintimammography using a dual-head, breast-specific gamma camera. The results from three blinded readers were averaged. In 88 patients, 128 cancers were found. The per-lesion sensitivity with the dual-head camera was 90% (115/128) for all lesions and 82% (50/61) for lesions 1 cm or smaller. Overall, MBI specificity (by patient) was 69%. The proportion of patients with cancer in this study was higher than might be expected in a screening population with suspicious lesions on mammography. In selecting patients, preference was given to those with a high suspicious of cancer or who were likely to have multifocal or multicentric disease.
In another study, Spanu (Spanu, 2008) evaluated 145 consecutive patients scheduled for breast biopsy. With an 86% prevalence of disease, the sensitivity of BSGI was 97.6% per patient (100% for tumors larger than 10 mm and 91.1% for tumors 10 mm or smaller). The per-lesion specificity was 86.4%. A total of 4 cancers were missed, 3 of which were detected by mammography. The authors suggest using BSGI for surgical planning or to avoid biopsy, but the negative predictive value (NPV), calculated to be 83%, is not high enough to forgo biopsy.
Brem (Brem, 2007) compared the performance of BSGI and MRI in 23 women with 33 indeterminate lesions. Eight patients had nine pathologically confirmed cancers. BGSI demonstrated a significantly greater specificity (71%, 95% CI: 49% to 87%) than MRI (25%, 95% CI: 11% to 47%; p<0.05). BSGI was comparable to MRI for sensitivity (BSGI, 89%, 95% CI: 51% to 99% vs. MRI, 100%, 95% CI: 63% to 100%), PPV (BSGI, 53%, 95% CI: 27% to 78% vs. MRI, 33%, 95% CI: 17% to 54%), and NPV (BSGI, 94%, 95% CI: 71% to 100% vs. MRI, 100%, 95% CI: 52% to 100%). The authors point out that the 100% sensitivity and 25% specificity of MRI is probably due to the small number of cancers in this study.
Conclusions: The value of BSGI in evaluating indeterminate or suspicious lesions must be compared to other modalities that would be used, such as spot views for diagnostic mammography. Given the relative ease and diagnostic accuracy of the gold standard of biopsy, coupled with the adverse consequences of missing breast cancer, the NPV of BSGI would have to be extremely high to alter treatment decisions. Since the NPV is partially determined by the prevalence of disease, the NPV will be lower in a population of patients with mammographic abnormalities highly suggestive of breast cancer than in a population of patients with mammographic abnormalities not suggestive of breast cancer. Therefore, any clinical utility of BSGI as an adjunct to mammography would vary according to the type of mammographic abnormalities included in the studies.
Retrospective Studies of BSGI for Women with a Mixed Set of Indications
Several retrospective studies examined the use of BSGI in women with mixed indications. Brem (Brem, 2008) examined the performance of BSGI in a retrospective study of 146 consecutive patients who had a mixed set of indications, including palpable lesions with no mammographic correlation, diagnosis of multicentricity or multifocality in women with known breast cancer, or screening women at high risk of breast cancer. The analysis was performed per lesion (n=167), not per patient. Eighty-three of the lesions were malignant (49.7%). The overall sensitivity of BSGI was 96.4% (95% CI: 92% to 99%), and the specificity was 59.5% (95% CI: 49% to 70%). The PPV was 68.8% (95% CI: 60% to 78%), and the NPV was 94.3% (95% CI: 88% to 99%). The performance of BSGI in detecting smaller tumors in particular requires further investigation. As the authors point out, additional larger studies are needed to confirm or modify these findings.
Park et al. (Park, 2013) compared the performance of BSGI performed shortly after injection of the radiotracer with dual-phase imaging, in which BSGI was repeated one hour after the injection. The assumption was that technetium-99 sestamibi uptake might persist on the delayed images for malignant lesions, while for benign conditions it would not, thereby reducing false positive results. The population consisted of 76 women (mean age 49.3 years, range 33-61) being evaluated for a palpable lesion or a diagnosis of multicentricity and/or multifocality in women with biopsy-proven breast cancer, women being screening for breast cancer, or women with multiple lesions detected by mammography or ultrasound in which BSGI is used to determine an appropriate biopsy site. Thirteen women had breast cancer. Comparing single-phase and dual-phase BSGI, the sensitivity was 77% and 69%, respectively (p=1.0); while the specificity was 83% and 95%, respectively (p=0.0078). Thus, the dual-phase imaging appeared to increase the specificity significantly without a significant effect on the sensitivity. However, as the authors note, the sample size was small.
Weigert (Weigert, 2012) reported data from a retrospective multicenter patient registry. This study analyzed 1,042 patients drawn from a total of 2,004 patients in the registry. Women included in the study had BSGI imaging, pathological diagnosis by biopsy, and at least 6 months follow-up. BSGI had been recommended for patients with at least two of the following indications: equivocal or negative mammogram/US and an unresolved clinical concern; personal history of breast cancer or current cancer diagnosis; palpable masses negative on mammogram or US; radiodense breast tissue; or high risk for breast cancer. In this population, BSGI had a reported sensitivity of 91%, a specificity of 77%, a positive predictive value of 57%, and a negative predictive value of 96%. In 139 patients with a suspicious lesion on mammography, BSGI imaging was negative in 21 cases, 13 of which were true-negatives and 8 of which were false-negatives.
Conclusions: The mix of indications in these studies makes it difficult to generalize the results or to determine whether the performance of BSGI varies by indication. Also, the accuracy of the test may vary by indication and its intended use. For example, high sensitivity is important if the objective is to identify multifocal or multicentric disease, while a high negative predictive value is desirable if the goal is to reduce the number of biopsies among women referred for biopsy.
Meta-Analysis of BSGI
Sun et al. (2012) performed a systematic review and meta-analysis on the “clinical usefulness of [BSGI] as an adjunct modality to mammography for diagnosis of breast cancer.” The authors included 19 studies in five separate analyses. Random effects models were used when there was substantial heterogeneity.
The first analysis assessed the diagnostic performance of BSGI based on 8 studies. Heterogeneity was substantial (I2=53% for sensitivity and I2=91% for specificity). The pooled sensitivity was 95% (95% CI: 93% to 96%), while the pooled specificity was 80% (95% CI: 78% to 82%). In their analysis, studies with different indications for BSGI were combined, and therefore the results on accuracy are difficult to interpret. They also conducted analyses on other groups of studies. The authors also used a modification of the original QUADAS instrument (Whiting et al. 2003), which was subsequently revised by the developers (Whiting et al. 2011).
No studies were identified that address the health outcomes of interest, nor is there sufficient indirect evidence to infer that the use of BSGI would produce changes in health outcomes.
Summary
The evidence to date does not provide sufficient support for any of the uses discussed. The published literature on BSGI, MBI, and scintimammography with breast-specific gamma camera is limited by a number of factors. The studies include populations that usually do not represent those encountered in clinical practice and that have mixed indications. There are methodologic limitations in the available studies, which have been judged to have medium to high risk of bias, and they lack information on the impact on therapeutic efficacy. Limited evidence on the diagnostic accuracy of BSGI reports that the test has a relatively high sensitivity and specificity for detecting malignancy. However, the evidence does not establish that BSGI improves outcomes when used as an adjunct to mammography for breast cancer screening. In the available studies, the negative predictive value of BSGI has not been high enough to preclude biopsy in patients with inconclusive mammograms. The relatively high radiation dose also should be taken into account. In addition, the evidence is not sufficient to conclude that BSGI is better than MRI for this purpose. Larger, higher-quality studies are required to determine whether BSGI has a useful role as an adjunct to mammography.
According to online site clinicaltrials.gov, about 12 trials are currently underway on BSGI or MBI, and many of them are being conducted at the Mayo Clinic. They include the following:
Practice Guidelines and Position Statements
As noted in the Description section, the Society for Nuclear Medicine released a procedure guideline on breast scintigraphy with breast-specific gamma camera (SNM, 2010). It lists a set of potential indications with references apparently to support each set of indications but does not provide a systematic review of the literature on the uses of breast scintigraphy with breast-specific gamma camera, which would take into account the quality of the studies. The guideline is based on consensus, and most of it is devoted to the procedures and specifications of the examination, documentation, and recording, quality control, and radiation safety.
The American College of Obstetricians and Gynecologists practice bulletin on breast screening notes scintimammography was considered but not recommended for routine screening (ACOG, 2011).
Appropriateness Criteria from the American College of Radiology for breast cancer screening, breast microcalcifications — initial diagnostic workup, palpable breast masses all rated BSGI a 1, which refers to “usually not appropriate” (ACR, 2012, ACR, 2009; ACR, 2012).
2014 Update
A literature search conducted through April 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Brem et al (2005) used a breast-specific gamma camera to evaluate 94 women considered at high risk of breast cancer, despite normal mammographic findings (Berm, 2005). High risk was defined as a 5-year breast cancer risk of 1.66%, as determined by the Gail model. Of 94 women in the study, 35 (37%) had a prior history of some type of breast cancer or atypical hyperplasia. Sixteen women (17%) had abnormal scintimammograms. Follow-up ultrasound in 11 of these identified a hypoechoic lesion that was biopsied. The 5 remaining patients had normal ultrasound results and were followed up with a repeat scintimammogram at 6 months, which was normal in all 5. Among the 11 women who underwent ultrasound-guided biopsy, 2 invasive cancers (12%) were identified. Sensitivity of BSGI was 100% (95% CI, 22 to 100), and specificity was 85%. The study was limited by the small number of cancers detected.
In a retrospective study of 341 women with biopsy-proven breast cancer, Rechtman et al (2014) determined the sensitivity of BSGI in dense versus nondense breasts (Rechtman, 2014). Mean patient age was 55 years (range, 28-89). All patients underwent preoperative BSGI and mammography; women with Breast Imaging Reporting and Data System (BI-RADS) density 1 or 2 were classified as having nondense breasts, and those with BI-RADS density 3 or 4 were classified as having dense breasts. Of 347 biopsy-proven breast cancers, BSGI was positive in 331 (overall sensitivity, 95%). In women with dense versus nondense breasts, BSGI sensitivity for detection of mammographically occult breast cancer did not differ statistically (97% vs 95%, respectively; c2, p=0.102).
In 2014, Tan et al assessed the diagnostic accuracy of dual-phase (at 10-15 minutes and at 90-120 minutes) BSGI in 76 women at a single institution in China who had suspicious breast masses (Tan, 2014). On pathologic review, 54 (59%) of 92 tumors were malignant and 38 (41%) were benign. Using receiver operating characteristic-determined cut points for visual and semiquantitative interpretation, sensitivity and specificity were maximized when a combination of visual and early phase semiquantitative interpretation was used (85% and 92%, respectively), compared with either analysis or delayed phase semiquantitative analysis alone.
Kim et al (2013) compared BSGI with dynamic contrast-enhanced MRI in 35 women who had pathologically diagnosed DCIS (Kim, 2013). Mean patient age was 48 years (range, 26-69). All patients underwent both BSGI and MRI. Overall sensitivity of BSGI and MRI were 69% and 91%, respectively. In 18 women who had microcalcifications on mammography, sensitivity of BSGI and MRI were 83% and 94%, respectively. In 17 women who had no microcalcifications on mammography, sensitivity of BSGI and MRI were 53% and 88%, respectively.
Bricou et al (2013) reviewed studies of recently-developed mobile gamma cameras for use during breast cancer surgery and/or sentinel lymph node (SLN) biopsy (Bricou, 2013). In this procedure, lymphatic drainage of radioactive colloid injected preoperatively in or around the tumor site is imaged. The review included clinical studies published between January 2000 and March 2012. Thirteen studies of 8 different gamma cameras, both hand-held and arm-mounted, were identified. For preoperative SLN detection, 3 studies (total N=245) reported the comparative accuracy compared with standard lymphoscintigraphy. One study (n=88) reported a sensitivity of mobile gamma cameras that was worse than standard lymphoscintigraphy, study (n=19) reported a better sensitivity, and the third study (n=138) reported noninferiority to standard lymphoscintigraphy. A potential bias in one study was performance of gamma imaging after lymphoscintigraphy, permitting longer migration of the radiotracer. For intraoperative SLN detection, 7 studies (total N=264) also reported mixed results.
Detection of Residual Tumor After Neoadjuvant Therapy
In a single-center, retrospective study, Lee et al (2014) evaluated BSGI detection of residual tumor after neoadjuvant chemotherapy (primarily anthracycline and taxane-based) in 122 women who had pathologically-confirmed invasive breast cancer (Lee, 2014). Mean patient age was 46 years (range 29-71). All patients underwent BSGI and dynamic contrast-enhanced breast MRI after completing neoadjuvant therapy. Surgeons consulted BSGI and MRI for surgical planning, ie, either breast-conserving therapy (64%) or mastectomy (36%). Of 122 patients, 104 (85%) had residual disease by pathologic review. BSGI sensitivity was 74%, specificity was 72%, NPV was 33%, and PPV was 94%. Sensitivity of BSGI varied with cellularity and size of residual tumor (greater sensitivity with greater cellularity and greater size).
Surgical Planning for Breast-Conserving Therapy
Edwards et al (2013) retrospectively assessed changes in surgical management of 218 women who had breast cancer and were eligible for breast-conserving therapy (Edwards, 2013). All patients had undergone preoperative BSGI or breast MRI. Twelve percent of patients who had BSGI and 29% of those who had MRI changed to mastectomy. On pathologic review, no patient who underwent mastectomy was eligible for breast-conserving therapy. Of patients who received breast-conserving therapy, 15% of those who had BSGI and 19% of those who had MRI required a single re-excision because of positive surgical margins, and 14% and 6%, respectively, required mastectomy. Based on this retrospective study, clinical utility of BSGI for guiding surgical decision making in breast cancer patients appears limited.
Park et al (2013) compared BSGI performed shortly after injection of the radiotracer with dual-phase imaging, in which BSGI was repeated 1 hour after the injection (Park, 2013). The assumption was that technetium Tc-99m sestamibi uptake might persist on delayed images for malignant lesions, but for benign conditions it would not, thereby reducing false positive results. The study sample comprised 76 women (mean age, 49 years, range 33-61) undergoing evaluation for a palpable lesion or for a diagnosis of multicentricity and/or multifocality in women with biopsy-proven breast cancer, women being screened for breast cancer, or women with multiple lesions detected by mammography or ultrasound in which BSGI was used to determine an appropriate biopsy site. Thirteen women had breast cancer. Comparing single-phase and dual-phase BSGI, sensitivity was 77% and 69%, respectively (p=1.0); specificity was 83% and 95%, respectively (p=0.008). Thus, dual-phase imaging appeared to increase specificity without a significant effect on sensitivity. However, as the authors noted, the sample size was small. In a subsequent retrospective study by Park et al (2014), diagnostic accuracy of BSGI was increased when both visual and semiquantitative readings (normalized for tracer uptake in the unaffected contralateral breast [background uptake]) were employed compared with visual analysis alone (Park, 2014).
2015 Update
A literature search conducted through June 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2015 Rhodes and colleagues reported a similar study that evaluated MBI (BSGI with dual-head CZT detectors) using a lower dose of technetium Tc-99m sestamibi (dispensed activity: 300 MBq [approximately 2.4 mSv] vs 740 MBq in conventional doses) (Rhodes, 2015). Like the earlier study, study participants were asymptomatic and had heterogeneously or extremely dense breasts. More than half (57%) had an additional risk factor for breast cancer conferring varying degrees of risk, eg, 10% had a personal history of breast cancer, and 22% (without personal history of breast cancer) had elevated Gail model risk. Of 1651 eligible women, 1585 (96%) underwent both mammography and MBI. Images were interpreted by radiologists blinded to results of the other test using a standardized lexicon, and reference standards included follow-up of both positive and negative test results for 11 months minimum. Twenty-one (1.3%) of 1583 women were diagnosed with cancer. For detection of all cancers (invasive cancers plus ductal carcinoma in situ), sensitivity was 24% (95% CI: 11 to 45) for mammography versus 91% (95% CI: 71 to 97) for mammography plus MBI (p<0.001); specificity was 89% (95% CI: 88 to 91) versus 83% (95% CI:81 to 85; p<0.001); positive predictive value (PPV) was 3% (95% CI: 1 to 7) versus 7% (95% CI: 4 to 10; p=0.021); and NPV was 99% (95% CI: 98 to 99) versus 100% (95% CI: 99 to 100; p<0.001), all respectively. The addition of MBI increased the recall rate from 11% with mammography alone to 18% (p<0.001) and the biopsy rate from 1% to 4% (p<0.001).
Evidence from multicenter, prospective, randomized trials on the use of BSGI for screening women with increased risk of breast cancer or in women with factors that limit the sensitivity of mammography is currently lacking. Furthermore, the relatively high radiation dose currently associated with BSGI has prompted the American College of Radiology to recommend against the use of BSGI for screening. In 1 study that used a reduced dose of technetium Tc-99m sestamibi, the effective dose (2.4 mSv) exceeded that of digital mammography (~0.5 mSv) by a factor of 4.8. Therefore, consideration of the potential use of BSGI for screening women with dense breasts or at high risk of breast cancer should wait the development of a lower-dose regimen, and if warranted, larger, higher quality studies with study populations representative of patients encountered in clinical practice. In addition, a large, high-quality head-to-head comparison of BSGI and MRI would be needed, especially for women at high risk of breast cancer, because MRI, alternated with mammography, is currently the recommended screening technique.
BSGI for Women with Indeterminate or Suspicious Lesions
Meissnitzer and colleagues (2015) in Austria evaluated BSGI in the diagnostic work-up of 67 patients with 92 breast lesions identified on mammography and/or ultrasound (Meissnitzer, 2015). Biopsy results were obtained as the reference standard in all patients, and 67 (73%) of 92 lesions were malignant. BSGI images were interpreted visually and semiquantitatively. Overall BSGI sensitivity and specificity were 90% and 56%, respectively, compared with ultrasound sensitivity and specificity of 99% and 20%, respectively. For lesions smaller than 1 cm, sensitivity of BSGI was 60%.
Ongoing and Unpublished Clinical Trials
Ongoing
NCT0062087) Evaluation of a Small Field of View Gamma Camera for Scintimammography in Patients With Atypical Ductal Hyperplasia, Atypical Lobular Hyperplasia, and Lobular Carcinoma In Situ; planned enrollment of 100; projected completion date December 2015.
(NCT01653964) Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing; planned enrollment 82; projected completion date April 2015 final data collection date for primary outcome measure, diagnostic accuracy.
(NCT01806558) Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions; planned enrollment 12; projected completion date December 2015
2017 Update
A literature search conducted through June 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Scintimammography, Breast-Specific Gamma Imaging, and Molecular Breast Imaging
Women with Dense Breasts or High Risk for Breast Cancer
Shermis and colleagues published retrospective studies that reported on women with dense breasts and negative mammograms (Shermis, 2016). The study sample was taken from a population of asymptomatic women who presented for routine breast cancer screening with mammography; a subset of these women were referred for supplemental screening. Women with BI-RADS category 1 or 2 findings on mammography (ie negative or benign) who had a BI-RADS density category C or D (ie heterogeneously or extremely dense) and whose lifetime risk was less than 20% according to the Gail model were recommended for supplemental BSGI screening. (Women with similar characteristics but a 20% or greater lifetime risk of breast cancer were recommended for MRI screening.) The BSGI protocol was similar to that used in the Rhodes et al Mayo clinic studies ie use of 300 MBq of technetium Tc-99m sestamibi. A total of 1696 women received supplemental BSGI, 143 (8.4%) had a positive finding and 13 (9%) of these 143 women were confirmed histopathologically as malignancies. Two of the malignancies were ductal carcinoma in situ and 11 were malignancies. Thus, the incremental cancer detection rate with BSGI was 0.77% (13/1696) and the invasive cancer rate was 0.65% (11/1696). The recall rate was 8.4% (143/1696). As the authors noted, follow-up was not conducted on all 1696 women so the sensitivity and specificity of BSGI in this study population cannot be determined.
Also in 2016, Brem and colleagues retrospectively reviewed findings of BSGI in 849 women at increased risk of breast cancer (eg, BRCA1, BRCA2, family history of breast cancer) whose mammogram findings were classified as negative, benign or probably benign (BI-RADS 1, 2, or 3) (Brem, 23016). BSGI examinations were performed with a single-head high-resolution breast-specific gamma camera. Initially, a mean of 781 MBq Tc-99m sestamibi (n=653) but then the protocol was modified to a mean of 296 MBq (n=196). A total of 212 (25%) of 849 women had a positive BSGI examination (recall rate). Fourteen (6.6%) of the 212 women who tested positive were found to have breast cancer. Eight of the 14 cancers were DCIS. The incremental cancer detection rate with BSGI was 1.6% (14/849) and the invasive cancer rate was 0.7% (6/849).
Women with Indeterminate or Suspicious Breast Lesions
In 2016, Cho and colleagues retrospectively reviewed breast lesions in 162 women who had been diagnosed with Bi-RADS 4 lesions (suspicious) on mammography or ultrasound (Cho, 2016). Patients had subsequently undergone BSGI with 925-1110 mBq of 99m-Tc-sestamibi. Using biopsy-confirmed pathologic evaluation as the criterion standard, 66 (40.7%) of 162 lesions were found to be malignant. The sensitivity and specificity of BSGI were 90.9% (95% CI, 81.3% to 96.6%) and 78.1% (95% CI, 68.5% to 85.9%), respectively. The PPV was 74.1% (95% CI, 63.1% to 83.2% and the NPV was 92.6% (95% CI, 94.6% to 97.2%). For lesions less than 1 cm, the sensitivity of BSGI was 88.8% (95% CI: 68.6 to 97.5%) and the specificity was 86.6% (95% CI, 71.% to 95.6%). For lesions greater than 1 cm, the sensitivity was higher (92.7%; 95% CI, 80.1% to 98.5%) and the specificity was lower (61.5%; 95% CI, 44.6 to 76.6%).
Detection of Residual Tumor after Neoadjuvant Therapy in Women with Breast Cancer
A 2016 systematic review and meta-analysis by Guo and colleagues identified 14 studies investigating the performance of technetium Tc-99m BSGI for evaluating the response to neoadjuvant therapy in patients with breast cancer (Guo, 2016). In all studies, histopathologic results were obtained after surgery and were used as the criterion standard. Study sizes ranged from 14 to 122 and there were a total of 503 patients. Most studies had fewer than 30 patients. Thirteen studies were prospective and 1 was retrospective. Only 3 studies conducted BSGI both before and after treatment. The sensitivity of BSGI for identifying residual disease ranged from 33% to 100%, with a pooled sensitivity of 86% (95% CI, 78% to 92%). The specificity ranged from 17% to 95% and the pooled specificity was 69% (95% CI, 64% to 74%).
No studies were identified that compared imaging methods eg BSGI versus MRI or 18-F FDG-PET [fluorine-18 fluorodeoxyglucose positron emission tomography] for detection of residual tumor after neoadjuvant therapy. In addition, no studies were identified on the clinical utility of BSGI, ie, changes in patient management strategies such as the extent of surgery or in health outcomes such as disease-specific survival.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed below:
Ongoing:
(NCT02324387) Tc99m Sestamibi Molecular Breast Imaging; planned enrollment 55; projected completion date June 2019.
(NCT02556684) Breast-Specific Gamma Imaging and Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy (BSGILAB); planned enrollment 200; projected completion date October 2020.
2018 Update
A literature search was conducted through June 2018. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
PRACTICE GUIDELINES AND POSITION STATEMENTS
American College of Obstetricians and Gynecologists
In 2017 the American College of Obstetricians and Gynecologists updated its 2011 practice bulletin on breast cancer screening (ACOG, 2017). There is no discussion or recommendation for scintimammography for routine screening in the 2017 practice bulletin.
American College of Radiology
Appropriateness Criteria from the American College of Radiology rated breast-specific gamma imaging a 1 or 2, indicating “usually not appropriate” for breast cancer screening, palpable breast masses (ACR, 2017) and workup of breast pain.
American Society of Clinical Oncology
The American Society of Clinical Oncology reaffirmed its 2014 recommendations on the use of sentinel node biopsy (SNB) for patients with early-stage breast cancer (ASCO, 2016). The recommendations were based on randomized controlled trials, systematic reviews, meta-analyses, and clinical practice guidelines from 2012 through July 2016. The recommendations included:
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Practice Guidelines and Position Statements
American College of Radiology
Appropriateness Criteria from the American College of Radiology rated breast-specific gamma imaging a 1 or 2 (indicating “usually not appropriate” for breast cancer screening), in patients with high or intermediate breast cancer risk (last reviewed in 2016), palpable breast masses (last reviewed in 2017), and workup of breast pain (last reviewed in 2016) (Moy, 2017; ACR, 2018). New guidelines on screening for breast cancer in above average risk patients (last reviewed in 2017) do not mention breast-specific gamma imaging (Monticciolo, 2018).
National Comprehensive Cancer Network
Network guidelines on breast cancer screening and diagnosis (v.2.2018) state: “Current evidence does not support the routine use of molecular imaging (e.g. breast-specific gamma imaging, sestamibi scan, or positron emission mammography) as screening procedures, but there is emerging evidence that these tests may improve detection of early breast cancers among women with mammographically dense breasts. However, the whole-body effective radiation dose with these tests is between 20-30 times higher than that of mammography (NCCN, 2018).”
2020 Update
A literature search was conducted through June 2020. There was no new information identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A retrospective review by Zhang et al was completed on 364 women with heterogeneously or extremely dense breasts who underwent mammography plus either BSGI or ultrasonography. Sensitivity increased by 25.23% with BSGI vs. 22.02% with ultrasonography (mean difference 3.21%; p=0.23) in women with false-negative mammograms. Specificity increased by 30.82% with BSGI vs. 20.55% with ultrasonography (mean difference 10.27%; p=0.003) in women with false-positive mammograms. Review revealed higher accuracy with mammography plus BSGI than mammography plus ultrasound or mammography alone (Zhang, 2020).
Thongvitokomarn et al published a meta-analysis comparing radioactive tracer or blue dye with indocyanine green fluorescence including 30 studies (N=4216 sentinel lymph node procedures) (Thongvitokomarn, 2020). The analysis evaluated detection rate, number of sentinel lymph nodes removed, and the rate of positive tumors comparing indocyanine green, blue dye, and radioactive tracer. Overall lymph node detection rates (total number of patients whose sentinel lymph nodes were detected by each tracer divided by total number of patients administered each tracer) were 69% to 100%, 65.6% to 97.1%, and 85% to 100% with indocyanine green, blue dye, and radioactive tracer, respectively. The detection rate was significantly different between indocyanine green and blue dye (odds ratio, 6.73; 95% CI, 4.20 to 10.78) but not between indocyanine green and radiotracer imaging (odds ratio, 0.90; 95% CI, 0.40 to 2.03). The number of sentinel lymph nodes removed were 2.35, 1.92, and 1.72 indocyanine green, blue dye, and radioactive tracer, respectively. Tumor positive rates were calculated by dividing the number of pathological positive sentinel lymph nodes by the total number of sentinel lymph nodes detected by each tracer and analyzed from 8 studies; 8.5% to 20.7% with indocyanine green, 12.7% to 21.4% with blue dye, and 11.3% to 16% with radiotracer.
Goonawardena et al compared radioactive tracer to indocyanine green fluorescence for SLNB in early-stage breast cancer; 19 studies were included (N=2301) (Goonawardena, 2020). Overall lymph node detection rates ranged from 81.9% to 100% with indocyanine green fluorescence and 85% to 100% with radiotracer. Sentinel lymph node detection was not different between groups (odds ratio, 0.93; 95% CI, 0.47 to 1.83); there was heterogeneity between studies with I2=58%; p=0.003. Tumor positive detection (sensitivity) based on 11 studies were 65.2% to 100% and 76.9% to 100% for indocyanine green fluorescence and radiotracer, respectively. No difference in sensitivity was found (odds ratio, 1.17; 95% CI, 0.43 to 3.17); there was heterogeneity between studies with I2=41%; p=0.09.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2023. No new literature was identified that would prompt a change in the coverage statement.
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