CAM 60136

Radioimmunoscintigraphy Imaging (Monoclonal Antibody Imaging) Using In-111 Satumomab Pendetide (OncoScint) or Tc-99m Arcitumomab (IMMU-4, CEA-Scan)

Category:Radiology   Last Reviewed:January 2019
Department(s):Medical Affairs   Next Review:January 2999
Original Date:December 2002    

Description
Radioimmunoscintigraphy (RIS) involves the administration of radiolabeled monoclonal antibodies (MAbs), which are directed against specific molecular targets, followed by imaging with an external gamma camera. MAbs that react with specific cellular antigens are conjugated with a radiolabeled isotope. The labeled antibody-isotope conjugate is then injected into the patient and allowed to localize to the target over a two- to seven-day period. The patient then undergoes imaging with a nuclear medicine gamma camera, and radioisotope counts are analyzed. Imaging can be performed with planar techniques or by using single-photon emission computed tomography (SPECT).

  • Indium-111 satumomab pendetide (CYT-103, OncoScint CR/OV®) has been approved by the U.S. Food and Drug Administration for imaging of colorectal and ovarian carcinomas.
  • Technetium-99m arcitumomab (IMMU-4, CEA-Scan®) has been approved by the FDA for use in colorectal and ovarian carcinoma.

These RIS agents have also been used in an off-label use to evaluate other malignancies including, but not limited to, breast cancer, lung cancer and thyroid cancer.

OncoScint is no longer commercially available.

Policy
Radioimmunoscintigraphy using satumomab pendetide or arcitumomab as the monoclonal antibody may be considered MEDICALLY NECESSARY in patients with known or suspected recurrent colorectal carcinoma under the following conditions:

  • In patients with an elevated carcinoembryonic antigen level, who have no evidence of disease with other imaging modalities (i.e., CT), in whom a second-look laparotomy is under consideration
  • Or in patients with an isolated, potentially resectable recurrence identified with conventional imaging modalities (i.e., CT), for whom the detection of additional occult lesions would alter the surgical plan

Other applications of radioimmunoscintigraphy using In-111satumomab pendetide or Tc-99m-arcitumomab  (IMMU-4, CEA-Scan) are considered INVESTIGATIONAL, including, but not limited to, ovarian cancer, breast cancer, medullary thyroid cancer and lung cancer.

Policy Guidelines:
PET scanning has largely replaced radioimmunoscintigraphy using satumomab pendetide or aricutmomab as the imaging technique of choice to evaluate for suspected recurrent colorectal carcinoma.

Rationale
Colon Cancer
The policy statement regarding RIS in patients with colorectal cancer is based on a 1994 TEC Assessment (1) that concluded that the evidence was adequate to conclude that radioimmunoscintigraphy improved health outcomes in certain patients with colorectal cancer. Specifically, positive findings on radioimmunoscintigraphy can affect the surgical management of patients with suspected occult cancer who would otherwise undergo second-look laparotomy due to a rising carcinoembryonic antigen (CEA) level, or resection of a metastasis that was incorrectly assumed to be an isolated lesion.

Additional review of the literature does not change the conclusions of the prior assessment. However, further reports have illustrated that RIS findings may yield false-positive findings such that biopsy or surgical confirmation of RIS findings may still be necessary to ensure appropriate patient management. (2-6) Furthermore, Dominguez et al. (7) reported in 15 patients with colorectal cancer that In-111 satumomab pendetide imaging had no effect on surgical management in 67 percent, a beneficial effect in 13 percent and a negative effect in 20 percent of cases.

Moffat et al. (8) reported a review of the literature using various RIS agents in colorectal cancer. In a multicenter trial also by Moffat et al. (9) using Tc-99m-arcitumomab, RIS results were associated with "potential clinical benefit" in 49 of 88 patients (56 percent) with suspected occult colorectal cancer recurrence. In a larger analysis from this same study, RIS results provided information that could have changed treatment planning in 89 of 210 (42 percent) patients.

Ovarian Cancer
The policy statement regarding RIS in patients with ovarian cancer is also based on a 1994 TEC Assessment (1) that concluded that the evidence was inadequate to determine whether its use was associated with beneficial health outcomes. Specifically, RIS has been investigated as a technique to select patients for second-look laparotomy after initial treatment for ovarian carcinoma. However, the assessment concluded that the positive predictive value of RIS was not fully reported in the available studies, and therefore it was not possible to determine whether the use of RIS was a reliable basis for making patient management decisions.

Additional review of the literature does not provide sufficient evidence to demonstrate the clinical effectiveness of RIS in ovarian cancer. (10-13) One study reviewed in the prior TEC Assessment, Surwit et al. (14), reports sensitivity of RIS with In-111 satumomab pendetide to be 68 percent in 103 subjects who had suspected or proven ovarian cancer before surgical management. However, when analysis was restricted to only patients with recurrent disease, sensitivity was only 59 percent. In the overall population, specificity was only 50 percent. Blend et al. (12) included 29 subjects with suspected recurrent ovarian cancer in a retrospective analysis of the impact of RIS using In-111 satumomab pendetide on management. In this study, clinical management was influenced in 19 of 299 cases. Surgery was initiated in three cases, canceled in one case and limited exploration was elected in two cases. Chemotherapy was started in eight cases. Several smaller studies combine reporting for results with colorectal cancer and ovarian cancer, yet the actual number of patients with ovarian cancer is very small, with only two in each study. (11,15)

Two studies evaluated the use of RIS prior to second-look laparotomy. (13,16) Method et al. (13) reported a prospective, blinded study in 20 subjects with ovarian cancer who had "normal CA 125 levels and no clinical evidence of disease after primary cytoreductive surgery and cytotoxic chemotherapy." All but two patients underwent reassessment laparotomy. Twelve patients had true-positive findings on RIS that were confirmed on laparotomy, and RIS sensitivity was calculated to be 100 percent, although specificity was relatively low at 16.7 percent. CT scanning showed relatively poor sensitivity (16.7 percent) but higher specificity (66.7 percent). Hempling et al. (16) studied 15 patients and found that RIS had a sensitivity of 62.5 percent and specificity of 57.1 percent. In patients with macroscopically visible tumor, disease location was correctly predicted by RIS in only 57 percent of cases.

These preliminary results suggest that RIS may possibly be useful in detecting additional sites of ovarian tumor in some cases, although reported sensitivity is variable. Specificity may be relatively low, and confirmation of positive findings may be necessary. Despite some evidence that RIS may be helpful in some cases where occult recurrence is suspected but cannot be localized, the relatively small size of most studies and the retrospective nature of the analyses without prospectively designed confirmation studies limits the conclusions that can be made from the available data.

Breast Cancer
Gopalan et al. (17) review various nuclear medicine techniques in breast cancer imaging and summarize findings using In-111 satumomab pendetide from a Phase I study by Lamki et al. (18) in 16 patients with primary breast cancer. While RIS detected all primary cancers (ranging in size from 1.2–2.5 cm), diagnostic accuracy in evaluating axillary lymph nodes was more limited with both false negative and false positive findings observed. Goldenberg (19) also mentions the use of anti-CEA RIS in evaluating breast cancer, but little empirical data was identified.

Medullary Thyroid Cancer
Medullary thyroid cancer may express carcinoembryonic antigen (CEA), and CEA levels are one method used to monitor disease for recurrence. Radiolabeled anti-CEA monoclonal antibodies have been applied as an adjunct to evaluate patients with medullary thyroid cancer; however, most of the identified studies (20-24) used indium- or iodine-labeled monoclonal antibodies, which are not the same as the FDA-approved technetium-labeled product. One study of 26 subjects included one subject who received the FDA-approved Tc-99m arcitumomab (IMMU-4; CEA-scan). In that case, RIS showed uptake in the three lesions that were also visible on CT.

Lung Cancer
The 1997 TEC Assessment (25) on radioimmunoscintigraphy for lung cancer reviews two studies and one abstract using Tc-99m arcitumomab (IMMU-4; CEA-Scan®, Immunomedics, Inc.) for evaluation of non-small cell lung cancer (NSCLC). These reports included relatively small samples, and some studies did not provide reporting of sensitivity and specificity. One study of 17 subjects found that RIS had 67 percent sensitivity in demonstrating 39 malignant lesions that were known to express CEA and that had been detected on conventional imaging techniques. It is not clear from these results how RIS would be useful in improving management and health outcomes.

Other Cancers
Bombardieri et al. (26) note that anti-CEA RIS has been used in evaluating other malignancies including pancreatic, gastric, and esophageal cancers, but there appears to be little evidence on this use.

Coding Section

Codes Number Description
CPT 78800 Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); limited area
  78801 Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); multiple areas
  78802 Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); whole body, single day imaging
  78803 Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); tomographic (SPECT)
  78804 Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); whold body, requiring two or more days imaging
  78890-78891  Generation of automated data; interactive process involving nuclear physician and/or allied health professional personnel; simple manipulations and interpretation, code range
ICD-9 Procedure 92.16 Scan of lymphatic system
  92.18 Total body scan, radioisotope
  92.19 Scan, other sites
ICD-9 Diagnosis (Codes given for medically necessary indications only) 154.0 Malignant neoplasm, colon with rectum
  183.0-183.9 Malignant neoplasm, ovary and other uterine adnexa, code range
  235.20 Neoplasm of uncertain behavior, intestine and rectum
  V10.04 Personal history malignant neoplasm, ovary
  V10.06 Personal history malignant neoplasm, rectosigmoid
HCPCS A4641 Supply of radiopharmaceutical diagnostic imaging agent, not otherwise classified
  A4642 Supply of satumomab pendetide, radiopharmaceutical diagnostic imaging agent, per dose
ICD-10-CM (effective 10/01/15)  C19 Malignant neoplasm of rectosigmoid junction 
  C569  Malignant neoplasm of unspecified ovary 
  C5700  Malignant neoplasm of unspecified fallopian tube 
  C5710  Malignant neoplasm of unspecified broad ligament 
  C573  Malignant neoplasm of parametrium 
  C5720  Malignant neoplasm of unspecified round ligament 
  C574  Malignant neoplasm of uterine adnexa, unspecified 
  D371  Neoplasm of uncertain behavior of stomach 
  D372  Neoplasm of uncertain behavior of small intestine 
  D374  Neoplasm of uncertain behavior of colon 
  D375  Neoplasm of uncertain behavior of rectum 
  Z85028  Personal history of other malignant neoplasm of stomach 
  Z85048  Personal history of other malignant neoplasm of rectum, rectosigmoid junction, and anus 
ICD-10-PCS (effective 10/01/15)  C71YYZZ Planar Nuclear Medicine Imaging of Lymphatic and Hematologic System using Other Radionuclide
  C72YYZZ Tomographic (Tomo) Nuclear Medicine Imaging of Lymphatic and Hematologic System using Other Radionuclide
  CW1N1ZZ Planar Nuclear Medicine Imaging of Whole Body using Technetium 99m (Tc-99m)
  CW1NDZZ Planar Nuclear Medicine Imaging of Whole Body using Indium 111 (In-111)
  CW1NFZZ Planar Nuclear Medicine Imaging of Whole Body using Iodine 123 (I-123)
  CW1NGZZ Planar Nuclear Medicine Imaging of Whole Body using Iodine 131 (I-131)
  CW1NLZZ Planar Nuclear Medicine Imaging of Whole Body using Gallium 67 (Ga-67)
  CW1NSZZ  Planar Nuclear Medicine Imaging of Whole Body using Thallium 201 (Tl-201) 
  CW1NYZZ  Planar Nuclear Medicine Imaging of Whole Body using Other Radionuclide 
  CW3NYZZ  Positron Emission Tomographic (PET) Imaging of Whole Body using Other Radionuclide 
  CF1C1ZZ Planar Nuclear Medicine Imaging of Hepatobiliary System, All using Technetium 99m (Tc-99m) 
  CF1CYZZ  Planar Nuclear Medicine Imaging of Hepatobiliary System, All using Other Radionuclide 
  CF1YYZZ  Planar Nuclear Medicine Imaging of Hepatobiliary System and Pancreas using Other Radionuclide 
  CG1YYZZ  Planar Nuclear Medicine Imaging of Endocrine System using Other Radionuclide 
  CG2YYZZ  Tomographic (Tomo) Nuclear Medicine Imaging of Endocrine System using Other Radionuclide 
  CH1YYZZ  Planar Nuclear Medicine Imaging of Skin, Subcutaneous Tissue and Breast using Other Radionuclide 
  CH2YYZZ  Tomographic (Tomo) Nuclear Medicine Imaging of Skin, Subcutaneous Tissue and Breast using Other Radionuclide 
  CT1YYZZ  Planar Nuclear Medicine Imaging of Urinary System using Other Radionuclide 
  CT2YYZZ  Tomographic (Tomo) Nuclear Medicine Imaging of Urinary System using Other Radionuclide 
  CV1YYZZ  Planar Nuclear Medicine Imaging of Male Reproductive System using Other Radionuclide 
  CW1YYZZ  Planar Nuclear Medicine Imaging of Multiple Anatomical Regions using Other Radionuclide 
  CW1ZZZZ  Planar Nuclear Medicine Imaging of Other Anatomical Region 
  CW2YYZZ  Tomographic (Tomo) Nuclear Medicine Imaging of Multiple Anatomical Regions using Other Radionuclide 
Type of Service Radiology  
Place of service Outpatient  

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2013 Forward     

01/30/2019 

Annual review, no change to policy intent 

01/29/2018 

Annual review, no change to policy intent. 

01/19/2017 

Annual review, no change to policy intent. 

01/11/2016 

Annual review, no change to policy intent. Deleted index. 

09/23/2015 

Added ICD-10 coding to policy. 

01/20/2015 

Annual review, no change to policy intent. Added coding. 

01/09/2014

Annual Review. No changes made. 

 


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