Is (99m)Tc-sestamibi scintimammography complementary to conventional mammography for detecting breast cancer in patients with palpable masses?

UNLABELLED: The aim of this trial was to evaluate in developing countries from different regions the diagnostic performance of (99m)Tc-sestamibi scintimammography (SM) in palpable breast lesions and to verify the clinical usefulness of a joint evaluation with mammography and SM. METHODS: From 10 countries, a total of 238 patients with palpable breast masses (n = 245) were included in this prospective multicenter trial. Prone SM was performed 10 min and 60-90 min (157 patients) after injection using an isotime acquisition of 10 min. Mammography was assessed by the same dedicated imaging radiologist according to breast imaging reporting and data system (BI-RADS) categories for malignancy and breast density. Masked SM findings and mammography findings were checked for a correlation with histopathology findings for excisional biopsy samples. Diagnostic values for breast cancer detection were calculated per lesion. RESULTS: Histopathology revealed 189 cancerous lesions and 56 benign lesions. The sensitivity and specificity of SM were 0.83 and 0.77, respectively. SM diagnostic values did not depend on the incidence of breast cancer in the country of origin or on the timing of imaging (early vs. delayed scans). On mammography, the technique yielded a sensitivity and specificity of 0.85 and 0.66, with 27 mammograms classified as BI-RADS category 1, 33 as category 2, 5 as category 3, 56 as category 4, and 124 as category 5. Thirty-seven lesions were considered to show increased radiologic density. No significant difference was found in SM diagnostic values among different BI-RADS categories or between the groups with low and high breast density. A sensitivity of 96% was calculated when SM and mammography results were combined, with 75% of all false-negative mammography findings classified as true-positive results by SM. CONCLUSION: SM complements mammography in patients with palpable masses and negative mammography findings.