OBJECTIVE:The purpose of this clinical trial was to determine the efficacy of a dynamic computerized infrared imaging system for distinguishing between benign and malignant lesions in patients undergoing biopsy on the basis of mammographic findings.

SUBJECTS AND METHODS:A 4-year clinical trial was conducted at five institutions using infrared imaging of patients for whom breast biopsy had been recommended. The data from a blinded subject set were obtained in 769 subjects with 875 biopsied lesions resulting in 187 malignant and 688 benign findings. The infrared technique records a series of sequential images that provides an assessment of the infrared information in a mammographically identified area. The suspicious area is localized on the infrared image by the radiologist using mammograms, and an index of suspicion is determined, yielding a negative or positive result.

RESULTS:In the 875 biopsied lesions, the index of suspicion resulted in a 97% sensitivity, a 14% specificity, a 95% negative predictive value, and a 24% positive predictive value. Lesions that were assessed as false-negative by infrared analysis were microcalcifications, so an additional analysis was performed in a subset excluding lesions described only as microcalcification. In this restricted subset of 448 subjects with 479 lesions and 110 malignancies, the index of suspicion resulted in a 99% sensitivity, an 18% specificity, a 99% negative predictive value, and a 27% positive predictive value. Analysis of infrared imaging performance in all 875 biopsied lesions revealed that specificity was statistically improved in dense breast tissue compared with fatty breast tissue.

CONCLUSION:Infrared imaging offers a safe noninvasive procedure that would be valuable as an adjunct to mammography in determining whether a lesion is benign or malignant.

AIM:To assess the ability of mammography and ultrasound individually and in combination to predict whether a breast abnormality is benign or malignant in patients with symptomatic breast disease.

MATERIALS AND METHODS:Patients included were those in whom histological confirmation of the abnormality following surgical excision was available. Mammographic and ultrasound appearances were prospectively classified using a four-point scale (1 = no significant lesion, 2 = benign lesion, 3 = possibly malignant, 4 = probably malignant).

RESULTS:Histological confirmation following surgical excision was available in 559 patients, of which 303 were benign and 256 were malignant. The imaging classification was correlated with histology in these 559 lesions. In predicting final histology, the sensitivity and specificity of mammography alone were 78.9 and 82.7%, respectively, of ultrasound alone were 88.9 and 77.9%, respectively, and of mammography and ultrasound in combination were 94.2 and 67.9%, respectively. Only one patient had both a mammogram and ultrasound reported as normal (category 1 for both tests) in whom subsequent histology revealed a carcinoma (0.4% of all carcinomas).

CONCLUSION:We found that the extensive use of ultrasound increases the cancer detection rate in this selected population by 14%.

INTRODUCTION:Recent reports have suggested that breast ultrasound (US) is of value in distinguishing malignant from benign processes. The aim of this study was to establish the accuracy of US in detecting invasive malignancy in clinically benign, discrete, symptomatic breast lumps.

METHODS:The US appearances of 205 clinically benign breast masses were documented prospectively and prior to mammography by one radiologist (AJE). The US appearances were then correlated with the fine needle aspiration (FNA), core biopsy and surgical findings and compared with the mammographic findings.

RESULTS:The US findings were normal 72 (35%), simple cyst 63 (31%), solid benign 51 (25%), solid indeterminate 15 (7%) and solid malignant four (2%). Ultrasound characterized 13 (93%) of the 14 patients found to have invasive carcinoma as indeterminate or malignant. No patients with normal or simple cyst US findings had invasive malignancy. Ultrasound had significantly better accuracy (97% vs 87%, P<0.02) sensitivity (93% vs 57%, P<0.05) and negative predictive value (99% vs 92%, P<0.002) than mammography in the detection of invasive carcinoma when indeterminate and malignant imaging findings were taken as positive.

CONCLUSION:US is a useful adjunct to FNA/core biopsy in confirming the nature of symptomatic, clinically benign breast masses and is superior to mammography in this clinical setting.