The purpose of this prospective study is to determine the diagnostic accuracy of near-infrared breast optical absorption imaging in patients with Breast Imaging Reporting and Data System (BIRADS) 4-5 non-palpable lesions scheduled for biopsy, using pathology after core or excisional biopsy as a reference. The patient's breast was positioned onto a panel of red light-emitting diodes (640 nm). A soft membrane was inflated to exert a uniform pressure on the breast. Transmitted light was detected using a CCD camera. The entire acquisition sequence took 1 minute. Image processing generated dynamic images displayed in colour scale, to reveal time-dependent changes in the transmitted light intensity caused by the pressure change. Dynamic curves were classified in two categories: consistently decreasing intensity suspicious for malignancy, and sinusoidal increasing intensity considered as benign. Seventy-eight women consulting for non-palpable breast lesions were initially included in the study. An imaging-histology correlation was obtained for seventy-two patients, the remaining six patients were excluded for technical optical scan reasons. We experienced an overall sensitivity of 73% and specificity of 38%, the false negative results being mainly small size (<10 mm) infiltrating malignant lesions and ductal carcinoma in situ (DCIS). False positive results were seen in benign proliferative lesions. Dynamic optical breast imaging is a novel, low-cost, non-invasive technique yielding a new type of information about the physiology of breast lesions. Absorption is due to haemoglobin and its products, therefore reflecting the angiogenic status of breast tumours.