Efficacy of Computerized Infrared Imaging Analysis to Evaluate Mammographically Suspicious Lesions
Published: American Journal of Radiology 2003
Abstract
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 X-Ray 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 an X-Ray Mammographically identified area. The suspicious area is localized on the Infrared image by the radiologist using X-Ray 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 Mammography offers a safe noninvasive procedure that would be valuable as an adjunct to X-Ray Mammography in determining whether a lesion is benign or malignant.
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