Diagnostic accuracy of 99mTc-sestamibi breast imaging: multicenter trial results.

UNLABELLED Although mammography is well established as a first-line tool for breast cancer screening and detection, efforts to develop complementary procedures continue. Observation of 99mTc-sestamibi tumor uptake provided the impetus for its evaluation as an adjunctive technique. This trial's objectives were to determine in a multicenter trial the diagnostic accuracy of 99mTc-sestamibi in women with suspected breast cancer and to investigate factors influencing diagnostic accuracy. METHODS Our multicenter trial enrolled 673 women (387 with nonpalpable abnormalities; 286 with palpable abnormalities) scheduled for excisional biopsy or mastectomy. Blinded and unblinded interpretations of scintigraphic images were compared with core laboratory established histopathologic diagnoses to define the diagnostic accuracy of 99mTc-sestamibi breast imaging. RESULTS Blinded readers' diagnostic accuracy was 78%-81%. Inter-reader agreement was excellent, ranging from 95% to 100% (kappa = 0.82-0.99). Overall institutional sensitivity and specificity for 99mTc-sestamibi breast imaging were 75.4% and 82.7%, respectively. In this population with a 40.1% disease prevalence, the positive predictive value was 74.5% and the negative predictive value was 83.4%. The negative predictive value was 94% in patients with a 40% or lower mammographic likelihood of breast cancer. Sensitivity was higher for palpable abnormalities; specificity was higher for nonpalpable abnormalities. Sensitivity was decreased for tumors <1 cm in largest dimension but appeared not to be affected by patient's age. CONCLUSION As an adjunct to current procedures, 99mTc-sestamibi breast imaging may contribute to patient management decisions in selected populations, including women with dense breasts, mammographically indeterminate lesions >1 cm, and palpable abnormalities.