International prospective evaluation of scintimammography with (99m)technetium sestamibi.

Background: The purpose of this study is to evaluate the efficacy of scintimammography with (99m)Technetium-Sestamibi for the diagnosis of breast cancer.

Methods: This was a multicenter prospective cohort clinical trial. A total of 1,734 women were enrolled of whom 1,243 had complete data upon study completion.

Results: The mean +/- standard error age of the patients is 56 +/-12 years (with a range of 19 to 94). Mammographic results were classified by the Breast Imaging Reporting and Data System (BIRADS) as 199 (16%) BIRADS 5, 149 (12%) BIRADS 4, 199 (16%) BIRADS 3, and 696 (56%) BIRADS 2 or 1. Scintimammography was positive for 322 (26%) of the patients and negative for 921 (76%). Histopathology showed malignancy for 201 (16%) of the patients. Sensitivity and specificity of scintimammography was estimated 93% and 87% respectively. A positive predictive value (PPV) of 58% with a negative predictive value of 98% were calculated.

Conclusions: The present study suggests that scintimammography with (99m)Technetium-Sestamibi is highly accurate for the detection of breast cancer.