Two hundred nine patients with breast disease were examined with a new advanced ultrasonic scanner. The ultrasound data were compared with clinical examination and, when available, X-ray, surgical, and pathologic observations. The main purpose of the study was to determine whether ultrasonic examination provides additional diagnostic information on breast disease, to compare the sensitivity of ultrasonic examination with other diagnostic modalities, and to define its clinical applications. mitted a more accurate, detailed description of the lesions than other modalities and was capable of detecting cysts as small as 0.2 cm in diameter. By the use of ultrasound, fibrocystic disease was correctly diagnosed in 97% of patients and confirmed the presence of palpable cystic masses in 95%. In 24 cases of histologically confirmed breast cancer, 16 were diagnosed initially by ultrasound and 18 on review, compared with 22 of 24 cases by X-ray mammography. Six of the eight initial false-negative cases belonged to the non-palpable group, where sonography could not visualize the presence of microcalcifications or radiologic mass identified by X-ray mammography. In two patients who refused mammography, cancer was diagnosed by ultrasound only.Our results demonstrate that ultrasound is a useful adjunct t o other techniques in the differential diagnosis of breast lesions; however, it is not an unqualified substitute for X-ray mammography. At present, we therefore consider that breast screening programs cannot be based on ultrasound alone. The main proven use of ultrasound is in the differential diagnosis of palpable lesions of the breast.