Coverage Policy Manual
Policy #: 2000001
Category: Radiology
Initiated: December 1999
Last Review: November 2023
  PET or PET/CT for Colorectal Cancer

Description:
Note:  This policy is intended for those members with contracts that do not have requirements for prior approval for imaging procedures through an independent imaging review organization.
 
 
Positron Emission Tomography (PET) imaging uses radiotracers that can reveal both anatomical and physiological information.  The glucose analog, 2-[fluorine-18]-Fluoro-2-deoxy-D-glucose (FDG) is useful in cancer imaging because it has been found that tumor cells show increased utilization of glucose compared to non-malignant tissue and is the most common radiotracer that is utilized. For certain malignancies PET scans have been shown to be more accurate than other non-invasive tests in detecting malignant disease.  However, as with all diagnostic tests, PET scans do not detect cancer 100% of the time that cancer is present (a false negative test), nor do all positive PET scans represent the presence of malignant disease (a false positive test).  A false negative test may occur because a critical volume of malignant cells is necessary for a PET scan to be positive. PET scans may be false positive in the presence of inflammation or granulomatous disease.
 
The aim of detecting hepatic or extrahepatic metastases is to:
    • More accurately determine those patients that would not benefit from surgery;
    • To more effectively plan the type of surgery needed; and
    • To evaluate for possible recurrence of disease after curative surgery.
 
PET has been shown to have a higher positive predictive value than Computed Tomography (CT) in detection of liver metastasis and correctly identifying the metastatic lesion(s).  PET has been found to have a higher positive predictive value than CT in determining extrahepatic metastases.
 
The use of PET to determine whether a possible abnormality found on CT is scar from previous surgery vs. residual or recurrent colorectal cancer has been reported in 6 studies.  The negative predictive value from the six studies was 8%, indicating that in 8 out of 100 patients, the result of the PET would have been negative when the patient actually had recurrent disease.  
 
The result of using of PET to monitor response to chemotherapy has been reported in a few series of small numbers of patients.  In these case series, the interval between tumor therapy and FDG-PET, as well as the method of quantification differ per study. Whether the result of monitoring chemotherapy or radiotherapy with PET improves health outcomes is unknown. Dynamic imaging is not a standard technique to evaluate tumor therapy.
 
Definitions
 
Screening – testing in the absence of an established or clinically suspected diagnosis
 
Diagnosis - testing based on a reasonable clinical suspicion of a particular condition or disorder
 
Diagnostic Workup – initial staging of documented malignancy
 
Management – testing to direct therapy of an established condition, which may include preoperative or postoperative imaging, or imaging performed to evaluate the response to nonsurgical intervention. In oncologic imaging, management applies to patients with measurable disease and to imaging performed before or after planned treatment intervention, therapy response, restaging or clinically suspected recurrence.
 
Surveillance – periodic assessment following completion of therapy. In oncologic imaging, surveillance applies to asymptomatic patients in remission and/or without measurable disease
 
Cannot be performed or is nondiagnostic – applies when the test:
    • Is positive or indeterminate for clinically significant pathology when the information provided about the abnormality by the test is not sufficient to direct subsequent management
    • Is negative when the negative likelihood ratio of the test is both insufficient to confidently exclude the absence of suspected disease and unable to direct subsequent management. This typically applies in scenarios with moderate to high clinical pretest probability with negative testing or low pretest probability with clear evidence for net benefit
    • Has been previously nondiagnostic because of a persistent clinical factor (e.g., body habitus, immobility) that is very likely to make retesting nondiagnostic as well Cannot be performed due to a medical contraindication (e.g., contrast nephrotoxicity, allergy, or in highly radiation sensitive populations such as pediatrics and pregnancy) or reasonable unavailability related to lack of local expertise or service availability
Standard or conventional imaging: Refers to imaging that does not require a PET/CT. Depending on the clinical scenario and individual patient circumstances, this may include computed tomography, magnetic resonance imaging, ultrasound and/or scintigraphy.

Policy/
Coverage:
EFFECTIVE MARCH 13, 2022
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT meets primary coverage criteria and is covered for patients with colorectal cancer for:  
 
Diagnostic Workup:
Indicated when standard imaging (CT Chest, Abdomen and Pelvis) cannot be performed or is non-diagnostic for surgically curable metastatic disease
 
Management:
Indicated in ANY of the following scenarios:
        • CT is equivocal for metastatic disease and lesion(s) is/are greater than 1 cm in diameter
        • CT demonstrates recurrence that is potentially curable with surgery
        • CT does not demonstrate a focus of recurrence, but carcinoembryonic antigen (CEA) level is rising
        • Signs or symptoms are suggestive of recurrence and CT is contraindicated
 
For all fully insured contracts, all self-funded church-sponsored health plans and all self-funded government-sponsored health plans other than the Arkansas State and Public School Employees program, the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.  
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT does not meet member certificate of benefit Primary Coverage Criteria for effectiveness and is not covered for patients with colorectal cancer for any indication or any circumstance other than those listed above including but not limited to:
    • Surveillance*
 
Positron emission tomography (PET) is considered investigational and is not covered for patients with colorectal cancer for any other indication not listed above. is considered investigational and is not covered for any indication or any circumstance other than those listed above including but not limited to:
    • Surveillance*
Investigational services are exclusions in the member certificate of coverage.
 
*For all fully insured contracts, all self-funded church-sponsored health plans and all self-funded government-sponsored health plans other than the Arkansas State and Public School Employees program, the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
  
Note: Standard or conventional imaging: Refers to imaging that does not require a PET/CT. Depending on the clinical scenario and individual patient circumstances, this may include computed tomography, magnetic resonance imaging, ultrasound and/or scintigraphy.
 
 
Effective Prior to March 13, 2022
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Positron emission tomography (PET) scanning meets primary coverage criteria for effectiveness and is covered for patients with colorectal cancer for:
 
Initial treatment: Detection of metastatic disease when:  
    • Standard imaging suggests resectable metastatic disease and confirmation will impact decision for curative surgery; OR
    • The lesions are > 1cm diameter and not amenable to biopsy or biopsy is considered high risk.
 
Subsequent treatment: when:  
    • Standard CT scan is equivocal for metastatic disease and lesions are > 1cm diameter; OR
    • Standard CT demonstrates potentially surgically curable recurrence; OR
    • Rising CEA, but CT negative for recurrence; OR
    • Signs/symptoms are suggestive of recurrence and contrast CT is contraindicated.
 
For all fully insured contracts, all self-funded church-sponsored health plans, and all self-funded government-sponsored health plans (e.g., state and public-school employee plans), other than the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET scan for patients with colorectal cancer is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:  
    • for monitoring response to therapy.
    • for surveillance of asymptomatic patients with no clinical, laboratory, or radiological evidence of recurrence.*
    • for any other indication not specifically listed as covered above.
 
*For all fully insured contracts, all self-funded church-sponsored health plans, and all self-funded government-sponsored health plans (e.g., state and public-school employee plans), other than the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
 
For contracts without primary coverage criteria, PET scanning for members with colorectal cancer, for the following indications are considered investigational and are not covered:  
    • for monitoring response to therapy
    • for surveillance of asymptomatic patients with no clinical, laboratory, or radiological evidence of recurrence.
    • for any other indication not specifically listed as covered above.  
Investigational services are exclusions in the member certificate of coverage.
 
Effective Prior to August 2021
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Positron emission tomography (PET) scanning meets primary coverage criteria for effectiveness and is covered for patients with colorectal cancer for:
 
Initial treatment: Detection of metastatic disease when:
 
    • Standard imaging suggests resectable metastatic disease and confirmation will impact decision for curative surgery; OR
    • The lesions are > 1cm diameter and not amenable to biopsy or biopsy is considered high risk.
 
Subsequent treatment: when:
 
    • Standard CT scan is equivocal for metastatic disease and lesions are > 1cm diameter; OR
    • Standard CT demonstrates potentially surgically curable recurrence; OR
    • Rising CEA, but CT negative for recurrence; OR
    • Signs/symptoms are suggestive of recurrence and contrast CT is contraindicated.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET scan for patients with colorectal cancer is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following indications:
 
    • for monitoring response to therapy.
    • for surveillance of asymptomatic patients with no clinical, laboratory, or radiological evidence of recurrence.
    • for any other indication not specifically listed as covered above.
 
For contracts without primary coverage criteria, PET scanning for members with colorectal cancer, for the following indications are considered investigational and are not covered:
 
    • for monitoring response to therapy
    • for surveillance of asymptomatic patients with no clinical, laboratory, or radiological evidence of recurrence.
    • for any other indication not specifically listed as covered above.
 
Investigational services are exclusions in the member certificate of coverage.
 
Effective prior to October 2019
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
"PET scan" refers to FDG PET or PET/CT.
 
Positron emission tomography (PET) scanning meets primary coverage criteria for effectiveness and is covered for patients with colorectal cancer:
  • When used to detect hepatic or extrahepatic metastases for initial staging.
  • For patients with previously diagnosed colorectal carcinoma when recurrence is suspected on the basis of clinical or biochemical findings (rising CEA) and/or by conventional imaging (e.g., CT, MRI).
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET scan for patients with colorectal cancer is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness:
  • for monitoring response to therapy
  • for surveillance of asymptomatic patients with no clinical, laboratory, or radiological evidence of recurrence
 
For contracts without primary coverage criteria, PET scanning for members with colorectal cancer, for the following indications are considered investigational and are not covered:
  • PET to monitor response to therapy
  • PET for surveillance of asymptomatic patients with no clinical, laboratory, or radiological evidence of recurrence for effectiveness as there are no studies which indicate improvement in health outcomes, and this use of PET is recommended against by NCCN.
 
Investigational services are an exclusion in the member certificate of coverage.
 
PET scanning should not be done for staging or re-staging of tumors that are known not to be 18FDG-avid. “Despite the intriguing and often persuasive findings of several studies investigating PET for monitoring the response during the course of therapy, no published reports have clearly demonstrated that PET results were used to alter treatment.” “Therefore clinical trials are needed to demonstrate the beneficial effect of early PET scanning on the treatment of patients and the ultimate outcomes. Until such effect is clearly shown, this application of PET remains experimental or exploratory.” (Juweid ME, Cheson BD. NEJM, 2006;354:496-507)

Rationale:
Joyce and colleagues (2006) published the results of a prospective cohort study completed on 71 consecutive patients referred with potentially resectable hepatic metastases based on conventional imaging findings  who underwent PET or PET/CT in the subsequent preoperative evaluation.  The PET findings confirmed the lesions identified by conventional imaging techniques in 64 (90%) of the patients. Additional lesions were identified on PET in 23 patients (32%). The information obtained by PET resulted in a change in clinical management in 17 cases (24%). False-positive PET findings occurred in 6 patients (8%), whereas false understaging occurred in 11 (15%). In no cases did PET findings have an adverse impact on patient outcome.  The authors concluded that PET provides useful information in the selection of patients with hepatic metastases from colorectal cancer being considered for surgical therapy. Such improved selection may serve to reduce the number of unnecessary surgical explorations and result in improved long-term survival in patients undergoing resection. Positron emission tomography should be integrated into the routine preoperative evaluation of patients being considered for hepatic resection of colorectal metastases.
 
Evidence in studies performed indicates that PET scanning adds useful information to conventional imaging in detecting hepatic and extrahepatic metastases. In particular, PET can detect additional metastases leading to more identification of non-resectable disease, allowing patients to avoid surgery. The strongest evidence comes from a study that directly assessed the additional value of PET. In a group of 37 patients thought to have solitary liver metastases by conventional imaging, PET correctly upstaged 4 patients and falsely overstaged 1 patient. This study and another further found that, when PET is discordant with conventional imaging, PET is correct in 88% and 97%, respectively, of patients. When PET affects management decisions, it is more often used to recommend against surgery.
 
When used to distinguish between local recurrence and scar, the comparison is between performing histologic sampling in all patients with a suspected local recurrence and avoiding sampling in patients whose PET scans suggest the presence of postoperative scar. The key concern is whether the negative predictive value for PET is sufficiently high to influence decision making, specifically to avoid tissue biopsy when the PET scan is negative. The available studies suggest a probability of false negative results of 8%, making it unlikely that patients and physicians would be willing to forgo histologic sampling and delay potentially curative repeat resection.
 
NCCN Guidelines Version 3.2013_Colon Cancer/ NCCN Guidelines Version 4.2013_Rectal Cancer
    • PET/CT should not be used to monitor progress of therapy.  
    • The consensus of the Panel is that a PET scan is not routinely indicated for clinical evaluation and staging of colon/rectal cancer.
    • Managing patients with an elevated CEA  level after resection should include colonoscopy; chest, abdominal, and pelvic CT scans; physical examination; and consideration of PET/CT scan.
    • On documentation of metachronous, potentially resectable, metastatic disease with dedicated contrast-enhanced CT or MRI, PET/CT scan should be considered for characterization of the disease extent.
    • Routine use of PET/CT to monitor for disease recurrence is not recommended.
 
 
A search on clinicaltrials.gov identified the following clinical trials:
    • NCT00265356 - Impact of Positron Emission Tomography Imaging Prior to Liver Resection for Colorectal Adenocarcinoma Metastases (PETCAM)_(Canada)Randomized, interventional.  Enrollment 404 with estimated completion date of April 2013.
 
    • NCT00588549 - Utility of PET In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases_(US) Observational, prospective; enrollment 204.  Study completed, but results are not yet published.
 
2014 Update
 
A literature search conducted through April 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
In a 2013 meta-analysis, Lu et al evaluated 510 patients from 11 studies on PET for colorectal cancer tumor recurrence detection in patients with CEA elevation (Lu, 2013).  FDG-PET and PET-CT pooled estimate sensitivities were 90.3% (95% CI, 85.5% to 94.0%) and 94.1% (95% CI, 89.4% to 97.1%), while specificities were 80.0% (95% CI, 67.0% to 89.6%) and 77.2% (95% CI, 66.4% to 85.9%), respectively.
 
The NCCN guideline for colon cancer “strongly discourages the routine use of PET-CT scanning for staging, baseline imaging or routine follow-up and recommends consideration of a preoperative PET-CT scan at baseline only if prior anatomic imaging indicates the presence of potentially surgically curable M1 disease”(NCCN 2014a). NCCN panel opinion is divided on appropriateness of PET-CT when CEA) level is rising but indicate it may be considered when imaging study results eg, a good quality CT scan, are normal.
 
The NCCN guideline for rectal cancer indicates PET-CT is “not routinely indicated” and “should only be used to evaluate an equivocal finding on a contrast-enhanced CT scan” (NCCN, 2014b).
  
2015 Update
 
A literature search conducted through January 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Three systematic reviews published in 2014 included overlapping studies that assessed the predictive value of FDG-PET/CT in patients with locally advanced rectal cancer who received neoadjuvant chemoradiotherapy (Li, 2014; Maffione, 2014; Memon, 2014).Various PET parameters were investigated (standardized uptake value [SUV], response index [percentage of SUV decrease from baseline to post-neoadjuvant treatment]), and cut-off values varied. Pooled sensitivities ranged from 0.74 to 0.82, and pooled specificities ranged from 0.64 to 0.85. The value of FDG-PET/CT in this setting has yet to be clarified.
 
Current NCCN guidelines for colon cancer “strongly discourage the routine use of PET/CT scanning for staging, baseline imaging, or routine follow-up and recommend consideration of a preoperative PET/CT scan at baseline only if prior anatomic imaging indicates the presence of potentially surgically curable M1 disease.” (NCCN, 2014a ) NCCN panel opinion was divided on appropriateness of PET/CT when CEA level is rising; PET/CT may be considered when imaging study results (eg, a good quality CT scan) are normal. Current NCCN guidelines for rectal cancer state that PET/CT is “not routinely indicated” and “should only be used to evaluate an equivocal finding on a contrast-enhanced CT scan.” (NCCN, 2014b)
  
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
CRC Diagnosis
A systematic review by Jones et al evaluated the role of 18F-FDG-PET and 18F-FDG-PET/CT compared with conventional imaging in the detection of primary nodal disease (Jones, 2015). Twelve studies met inclusion criteria (total N=494 patients), Meta-analysis for detecting primary disease in situ showed that PET and PET/CT had a higher sensitivity (99%; 95% CI, 96% to 100%) than CT alone (60%; 95% CI, 46% to 75%).
 
CRC Staging
A meta-analysis by Ye et al assessed the use of 18F-FDG-PET/CT in preoperative TNM staging of CRC (Ye, 2015). The literature search, conducted through July 2014, identified 28 studies for inclusion. Of the 28 studies, 12 assessed tumor detection rate; 4 evaluated T staging, 20 N staging, and 5 M staging; while 8 examined stage change. Using the QUADAS tool, all studies met 9 or more of the 14 criteria.
 
CRC Restaging
A meta-analysis by Rymer et al evaluated use of 18F-FDG-PET/CT in the assessment of the response of locally advanced rectal cancer to neoadjuvant chemoradiotherapy (Rymer, 2016). The literature search, conducted through April 2014, identified 10 studies (total N=538 patients) for inclusion in the analysis. Selected studies were high quality, complying with an average 12.7 items on the 14-item QUADAS checklist. Tumors confirmed to have regressed following chemoradiotherapy (responders) had a higher response index mean difference of 12% (95% CI, 7% to 18%) and a lower standardized uptake value of -2.5 (95% CI, -3.0 to -1.9%) compared with nonresponders.
 
A meta-analysis by Yu et al evaluated the diagnostic value of 18F-FDG-PET/CT for detecting local recurrent colorectal cancer (Yu, 2015). The literature search, conducted through October 2014, identified 26 studies (total N=1794 patients) for inclusion. Study quality was assessed using QUADAS. Pooled
sensitivity and specificity were 95% (95% CI, 93% to 97%) and 93% (95% CI, 92% to 95%), respectively.
 
Maffione et al conducted a systematic review of 18F-FDG-PET for predicting response to neoadjuvant therapy in patients with rectal cancer (Maffione, 2015). The literature search was conducted through January 2014, with 29 studies meeting inclusion criteria for the meta-analysis. The studies had QUADAS scores ranging from 8 to 14 (median, 12). The pooled sensitivity and specificity for 18F-FDG-PET assessment of response to chemoradiotherapy in locally advanced rectal cancer were 73% (95% CI, 71% to 76%) and 77% (95% CI, 75% to 79%), respectively.
 
Evidence for the detection of primary nodal disease, staging, restaging, and detecting recurrence of colorectal cancer consists of a TEC Assessment and several meta-analyses published after the assessment. A meta-analysis evaluating the diagnostic accuracy of PET or PET/CT found a high
sensitivity but a low specificity. Several pooled analyses evaluating staging or restaging using PET or PET/CT resulted in sensitivities and specificities ranging low 60s to high 90s. The evidence for the use of PET or PET/CT did not show a benefit over the use of contrast CT in patients with colorectal cancer. The evidence does not support the use of 18F-FDG-PET and 18F-PET/CT for the diagnosis, staging and restaging, or surveillance of CRC.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement.  
 
2020 Update
A literature search was conducted through January 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 January 2021. No new literature was identified that would prompt a change in the coverage statement.
 
November 2021 Update
A literature review was performed through September 2021. Following is a summary of the key literature to date.
 
DIAGNOSTIC WORKUP
Colorectal cancer is staged using the American Joint Committee on Cancer TNM system. For colon cancer, the NCCN recommends CT chest, abdomen, and pelvis for initial staging. (1) In a meta-analysis of 19 studies evaluating CT imaging in preoperative colorectal staging, the pooled sensitivity and specificity for detection of tumor invasion were 86% (95% CI, 78%-92%) and 78% (95% CI, 71%-84%). Similarly, the values for nodal detection were 70% (95% CI, 63%-73%) and 78% (95% CI, 73%-82%). In a subgroup analysis, studies utilizing multi-detector CT fared better than conventional CT.(2) Results from this meta-analysis are consistent with the findings of several other studies. (3-8) MRI pelvis or endoscopic rectal ultrasound (ERUS) is indicated for the initial staging of rectal cancer, in addition to CT chest and abdomen. (9) In the prospective MERCURY II trial, MRI pelvis was able to accurately assess the low rectal plane which resulted in avoidance of overtreatment through selective preoperative therapy and substantially fewer pathologically positive circumferential resection margins. (10) PET/CT does not supplant a diagnostic contrast enhanced CT and should only be used to evaluate an equivocal finding or in patients with strong contraindications to IV contrast. Two studies found that PET/CT was not superior to CT for routine preoperative staging of colorectal cancer. In a study by Furukawa et al., PET/CT findings resulted in treatment changes in only 2% of patients who had bone and distant lymph node metastases detected only by PET/CT. In one case, CT imaging detected lung metastases that were not demonstrated on PET. (11) PET/CT may be useful in identifying additional sites of extrahepatic metastases, but a positive impact on overall management and survival has not been definitively established. In the setting of resectable M1 disease, Moulton et al found that PET/CT compared with CT alone did not influence survival. Surgical management was affected in 8% of patients, in which only 2.7% were deemed to no longer be surgical candidates. In addition, the false positive rate of PET/CT was 8.4%. (12)However, a meta-analysis of 18 studies suggests that FDG PET/CT is highly accurate for the detection of liver metastases on a per-patient basis but less accurate on a per-lesion basis. Compared to MRI, PET was
less sensitive but more specific, and impacted management in about 25% of patients. (13)
 
MANAGEMENT
Response to neoadjuvant therapy can be seen in as many as 60% and complete response in as many as 18% of patients with rectal cancer. (14, 15) In the prospective MERCURY study, MRI assessment of tumor response and circumferential resection margin was correlated with positive survival outcomes. (16) A recent meta-analysis by de Jong et al, however, concluded that MRI, CT, and ERUS could not be used to predict complete response of locally advanced rectal cancer, and had poor accuracy for predicting lymph node involvement and tumor invasion in the circumferential resection margin. (17) Chemotherapy may reduce the sensitivity of PET for the detection of liver metastases, likely due to metabolic inhibition caused by cytotoxic therapies.18, 19False negative rates of 87% have been reported for PET scans performed within 4 weeks of chemotherapy.20 False positive PET/CT scans may also result from tissue inflammation after surgery. In the uncommon setting of a rising carcinoembryonic antigen (CEA) and CT scans which have not identified a site of recurrence, PET/CT is a consideration; however, surgically curable recurrent disease may not be identified. It is notable that almost half of elevated CEAs after R0 resection are false positives and serial CTs at 3-month intervals until CEA stabilizes or normalizes or until disease is identified is often the preferred approach. When the CEA level is above 15ng/mL, false negatives are rare.21 Based on a pooled analysis for detection of colorectal cancer recurrence, the
sensitivity of CEA ranges from 68% for a threshold of 10 µg/L to 82% for a threshold of 2.5 µg/L and the specificity ranges from 97% for a threshold of 10 µg/L to 80% for a threshold of 2.5 µg/L.22 A meta-analysis of 11 studies estimated sensitivity and specificity and positive and negative likelihood ratios of FDG-PET/CT in the detection of tumor recurrence in colorectal cancer patients with elevated CEA to be 94.1%, 77.2%, 4.70, and 0.06, respectively. (23)
 
SURVEILLANCE
Surveillance CT chest, abdomen and pelvis is indicated for stage II and higher colon cancer per the NCCN at variable intervals depending on stage of disease. (1) For patients who have undergone local
transanal excision of rectal cancer, the NCCN recommends surveillance imaging with MRI or EUS of the rectum every 3-6 months for 2 years, then every 6 months for a total of 5 years. (9) Although PET/CT detects recurrence earlier in some patients, these benefits are offset by both false positive and false
negative results. A trial randomizing patients (N =130) treated with curative resection to conventional surveillance alone or conventional surveillance plus PET/CT scan found no significant difference in detection of recurrence between the 2 groups. The use of PET/CT in the setting of metastatic colorectal cancer treated with definitive therapy is also not indicated. A recent retrospective study failed to show a correlation with frequency of imaging and effect on time to second procedure or median survival duration. (24)
 
For surveillance of colorectal cancer, AIM Oncologic Imaging guidelines are in concordance with the American Society of Clinical Oncology recommendations, National Comprehensive Cancer Network (NCCN)Guidelines for Colon Cancer, and NCCN Guidelines for Rectal Cancer. (1, 9, 25)
 
Current References
    1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer (Version 2.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
    2. Dighe S, Purkayastha S, Swift I, et al. Diagnostic precision of CT in local staging of colon cancers: a metaanalysis. Clin Radiol. 2010;65(9):708-19. PMID: 20696298
    3. Dighe S, Blake H, Koh MD, et al. Accuracy of multidetector computed tomography in identifying poor prognostic factors in colonic cancer. Br J Surg. 2010;97(9):1407-15. PMID: 20564305
    4. Dighe S, Swift I, Magill L, et al. Accuracy of radiological staging in identifying high-risk colon cancer patients suitable for neoadjuvant chemotherapy: a multicentre experience. Colorectal Di s. 2012;14(4):438-44. PMID: 21689323
    5. Hundt W, Braunschweig R, Reiser M. Evaluation of spiral CT in staging of colon and rectum carcinoma. Eur Radiol. 1999;9(1):78-84. PMID: 9933385
    6. McAndrew MR, Saba AK. Efficacy of routine preoperative computed tomog raphy scans in colon cancer. Am Surg. 1999;65(3):205-8. PMID: 10075291
    7. Nerad E, Lahaye MJ, Maas M, et al. Diagnostic accuracy of CT for local staging of colon cancer: a systematic review and meta-analysis. AJR Am J Roentgenol. 2016;207(5):984-95. PMID: 27490941
    8. Smith NJ, Bees N, Barbachano Y, et al. Preoperative computed tomography staging of nonmetastatic colon cancer predicts outcome: implications for clinical trials. Br J Cancer. 2007;96(7):1030-6. PMID: 17353925
    9. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Rectal Cancer (Version 1.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
    10. Battersby NJ, How P, Moran B, et al. Prospective validation of a low rectal cancer magnetic resonance imaging staging system and development of a local recurrence risk stratification model: the MERCURY II study. Ann Surg. 2016;263(4):751-60. PMID: 25822672
    11. Furukawa H, Ikuma H, Seki A, et al. Positron emission tomography scanning is not superior to whole body multidetector helical computed tomography in the preoperative staging of colorectal cancer. Gut. 2006;55(7):1007-11. PMID: 16361308
    12. Moulton CA, Gu CS, Law CH, et al. Effect of PET before liver resection on surgical management for colorectal adenocarcinoma metastases: a randomized clinical trial. JAMA. 2014;311(18):1863-9. PMID: 24825641
    13. Maffione AM, Lopci E, Bluemel C, et al. Diagnostic accuracy and impact on management of (18)F-FDG PET and PET/CT in colorectal liver metastasis: a meta-analysis and systematic review. Eur J Nucl Med Mol Imaging. 2015;42(1):152-63. PMID: 25319712
    14. Park IJ, You YN, Agarwal A, et al. Neoadjuvant treatment response as an early response indicator for patients with rectal cancer. J Clin Oncol. 2012;30(15):1770-6. PMID: 22493423
    15. Das P, Skibber JM, Rodriguez-Bigas MA, et al. Predictors of tumor response and downstaging in patients who receive preoperative chemoradiation for rectal cancer. Cancer. 2007;109(9):1750-5. PMID: 17387743
    16. Patel UB, Taylor F, Blomqvist L, et al. Magnetic resonance imaging-detected tumor response for locally advanced rectal cancer predicts survival outcomes: MERCURY experience. J Clin Oncol. 2011;29(28):3753-60. PMID: 21876084
    17. de Jong EA, ten Berge JC, Dwarkasing RS, et al. The accuracy of MRI, endorectal ultrasonography, and computed tomography in predicting the response of locally advanced rectal cancer after preoperative therapy: a metaanalysis. Surgery. 2016;159(3):688-99. PMID: 26619929
    18. Akhurst T, Kates TJ, Mazumdar M, et al. Recent chemotherapy reduces the sensitivity of [18F] fluorodeoxyglucose positron emission tomography in the detection of colorectal metastases. J Clin Oncol. 2005;23(34):8713-6. PMID: 16314631
    19. van Kessel CS, Buckens CF, van den Bosch MA, et al. Preoperative imaging of colorectal liver metastases after neoadjuvant chemotherapy: a meta-analysis. Ann Surg Oncol. 2012;19(9):2805-13. PMID: 22396005
    20. Glazer ES, Beaty K, Abdalla EK, et al. Effectiveness of positron emission tomography for predicting chemotherapy response in colorectal cancer liver metastases. Arch Surg. 2010;145(4):340-5; discussion 5. PMID: 20404283
    21. Litvak A, Cercek A, Segal N, et al. False-positive elevations of carcinoembryonic antigen in patients with a history of resected colorectal cancer. J Natl Compr Canc Netw. 2014;12(6):907-13. PMID: 24925201
    22. Nicholson BD, Shinkins B, Mant D. Blood measurement of carcinoembryonic antigen Level for detecting recurrence of colorectal cancer. JAMA. 2016;316(12):1310-1. PMID: 27673308
    23. Lu YY, Chen JH, Chien CR, et al. Use of FDG-PET or PET/CT to detect recurrent colorectal cancer in patients with elevated CEA: a systematic review and meta-analysis. Int J Colorectal Dis. 2013;28(8):1039-47. PMID:23407908
    24. Hyder O, Dodson RM, Mayo SC, et al. Post-treatment surveillance of patients with colorectal cancer with surgically treated liver metastases. Surgery. 2013;154(2):256-65. PMID: 23889953
    25. Meyerhardt JA, Mangu PB, Flynn PJ, et al. Follow-up care, surveillance protocol, and secondary prevention measures for survivors of colorectal cancer: American Society of Clinical Oncology clinical practice guideline endorsement. J Clin Oncol. 2013;31(35):4465-70. PMID: 24220554
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2022. No new literature was identified that would prompt a change in the coverage statement.
 
NCCN Guidelines for Colon Cancer (Version 1.2022) and Rectal Cancer (Version 1.2022) were reviewed with no change from 2021 version with regard to PET applications.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:
78811Positron emission tomography (PET) imaging; limited area (eg, chest, head/neck)
78812Positron emission tomography (PET) imaging; skull base to mid thigh
78813Positron emission tomography (PET) imaging; whole body
78814Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; limited area (eg, chest, head/neck)
78815Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; skull base to mid thigh
78816Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; whole body

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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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