DESCRIPTION
Radioimmunoscintigraphy involves the administration of radio-labeled 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 radio-labeled isotope. Indium-111 capromab pendetide (e.g., ProstaScint®) targets an intracellular binding site on prostate-specific membrane antigen (PSMA). The labeled antibody-isotope conjugate is injected into the individual and allowed to localize to the target over a 2- to 7-day period. The antibodies may light up in areas where the cancer has spread because they are radioactive. The individual 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).
POLICY
Radioimmunoscintigraphy imaging with indium-111 capromab pendetide for the diagnosis, treatment or management of prostate cancer is considered investigational.
IMPORTANT REMINDER
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ADDITIONAL INFORMATION
Current medical literature is insufficient to support conclusions concerning efficacy, optimal use and impact on the diagnosis, treatment or clinical management of prostate cancer using radioimmunoscintigraphy imaging with Indium-111 capromab pendetide. The available studies do not provide consistent verification of disease status. Or demonstrate how radioimmunoscintigraphy results affected disease management.
Radioimmunoscintigraphy imaging also continues to be a challenge to interpret. A number of papers described ongoing efforts related to fused SPECT-CT images in patients with prostate cancer as an approach to improve the accuracy and clinical utility of this imaging technique.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2008). Radioimmunoscintigraphy imaging (monoclonal antibody imaging) with indium-111 capromab pendetide (ProstaScint®) for prostate cancer (6.01.37). Retrieved February 8, 2011 from BlueWeb. (32 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Evidence Reports. (2000, October). 111In-capromab pendetide for staging prostate cancer in men at high risk of metastasis. Retrieved June 25, 2009 from ECRI Institute. (62 articles and/or guidelines reviewed)
Haseman, M. K., Rosenthal, S. A., Kipper, S. L., Trout, J. R., & Manyak, M. J. (2007). Central abdominal uptake of indium-111 capromab pendetide (ProstaScint®) predicts for poor prognosis in patients with prostate cancer. Urology, 70 (2), 303-308. (Level 4 evidence - Industry sponsored)
National Comprehensive Cancer Network. (2011, January). NCCN clinical practice guidelines in oncology™. Prostate cancer - V.1.2011. Retrieved February 15, 2011 from http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
National Guideline Clearinghouse. (2007). ACR Appropriateness Criteria® pretreatment staging prostate cancer. Retrieved June 26, 2009 from http://www.guidelines.gov.
U. S. Food and Drug Administration. (1996, October). Center for Drug Evaluation and Research. Product Approval Information - Licensing Action. Capromab Pendetide. Retrieved February 15, 2011from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080734.htm.
Winifred S. Hayes. Medical Technology Directory. (2007, November; Last update search December 2010). Indium in 111 capromab pendetide (ProstaScint®) radioimmunoscintigraphy for the diagnosis of prostate cancer. Retrieved February 15, 2011 from www.Hayesinc.com/subscribers. (50 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 11/10/2007
MOST RECENT REVIEW DATE: 4/14/2011
ID_BA
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