Computerized thermal breast imaging revisited: an adjunctive tool to mammography

Physical examination and mammography are the primary methods for the detection of breast cancer, but lead to a high rate of benign biopsies. A digital thermal imaging system was developed as an adjunct to mammography to aid in the differentiation of benign from malignant lesions. Patients scheduled for biopsy were enrolled after informed consent. Prior to biopsy, digital thermal images were acquired of each breast during a 3.5 minute procedure. A probability of malignancy was assigned to each pixel, based on comparative statistical analysis of the thermal response features from the test subjects with data derived from lesions of known pathology. One hundred and seventeen female patients (125 suspicious lesions) were included, with a 24% true malignancy rate. Receiver Operating Characteristics (ROC) curves (Sensitivity vs. 1-Specificity) were generated based on various features of the cooling model. Based on the ROC curve analysis, 36/95 benign biopsies (38%) could have been avoided using this technology, while maintaining a sensitivity of 96%. Digital thermal imaging appears to be a valuable adjunct to mammography in the management of breast lesions, potentially decreasing the number of benign biopsies. Multi-institutional FDA clinical trials are currently underway