Miraluma scintimammography – pro

Scintimammography is a diagnostic modality using radiopharmaceuticals to provide tumor-specific imaging of the breast. Scintimammography has been proposed primarily as an adjunct to mammograms as a technique to improve patient selection for biopsy. If sufficiently predictive of benign lesion, scintimammography might be used to recommend against performing a biopsy, thus reducing the number of negative biopsies. If scintimammography accurately assesses axillary lymph node status, patients might either undergo needed axillary dissection or avoid it when unnecessary.
Various different radiopharmaceuticals may be used, including but not limited to technetium-99m sestamibi (Miraluma®), thallium-201, indium-111 satumomab pendetide (Oncoscint CR/OV®), and technetium-99m arcitumomab (CEA-Scan®). At the present time, only technetium-99m sestamibi has specific FDA approval for use in breast imaging. The labeling states that technetium-99m arcitumomab (CEA-Scan®). At the present time, only technetium- 99m sestamibi is a second-line diagnostic test after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram of breast mass. It is not indicated for breast cancer screening or to confirm the presence or absence of malignancy, and it is not an alternative to biopsy prompted by an abnormal mammogram or breast mass.

Medicare covers this test under soe conditions: “Miraluma as an aid in mammography will be covered with the following indication: Medical record indicates radiopharmaceutical used as a second line diagnostic drug after mammography to assist in the evaluation of a new breast lesion with abnormal mammogram or new palpable breast mass. Miraluma will not be covered if utilized for breast cancer screening, or for confirmation of presence or absence of malignancy of the breast. Miraluma is not an alternative to biopsy or mammogram. Miraluma is not covered for diagnoses of fibrocystic disease or pre-existing mass. Many private payers deny payment in allc ases basing themselves on a BCBS TEC assessment of 1997. A 1997 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment (2) reviewed the available published evidence for this indication and concluded that as a second-line diagnostic test after mammography, the sensitivity and corresponding negative predictive value of scintimammography were not high enough to influence treatment decisions. Specifically, even at the low end of the intermediate range of prevalence for malignancy, if a negative scintimammogram were to be used to recommend against doing biopsy, the risk of undetected malignancy would be 4.5%. This was considered too high given the relatively low morbidity of breast biopsy, the gold standard. An updated search of the published literature identified an additional small case series focusing on patients with microcalcifications; scintimammography was used to deselect patients for biopsy. The negative predictive value in this study was only 63%.


Agency for Healthcare Research & Quality. (2006, February). Noninvasive tests may miss breast cancer, AHRQ study finds. Retrieved from http://hstat.nlm.nih.gov/ftrs/dbaccess/htr95-9.

Brem, R. F., Rapelyea, J. A., Zisman, G., Mohtashemi, K., Raub, J., Teal, C. B., et al. (2005). Occult breast cancer: Scintimammography with high-resolution breast-specific gamma camera in women at high risk for breast cancer. Radiology, 237 (1), 274-280.

Health Technology Assessment Information Service. TARGET database. (2000, August). Scintimammography. Retrieved March 29, 2006 from ECRI HTAIS.

Liberman, M., Sampalis, F., Mulder, D. S., & Sampalis, J. S. (2003). Breast cancer diagnosis by scintimammography: A meta-analysis and review of the literature. Breast Cancer Research and Treatment, 80 (1), 115-126.

Polan, R. I., Klein, B. D., & Richman, R. H. (2001). Scintimammography in patients with minimal mammographic or clinical findings. Radiographics, 21 (3), 641-653.

TEC Assessment: Scintimammography, 1997; BlueCross and BlueShield Association Technology Evaluation Center, Vol. 12, No. 19

Participate in our Forums

To ask questions or participate in a discussion, please visit our Forums. You must LOGIN to participate.

Help Us Help Others

You can become a Site Sponsor. Or you may wish to support our work with a Donation.

Focused Articles For You

Lay Portal