Infrared Imaging (Breast Scan IR) for Early Breast Cancer Detection

The research study will evaluate the sensitivity and specificity of a new non-invasive digital infrared imaging system as an adjunctive test for breast cancer detection (as approved by the FDA under 21 CFR 884.2980). The technology and device (BreastScan IRÔ) have been developed by Infrared Sciences Corp. and has undergone more than 3 years of preliminary testing. The device's utility will be investigated with regard to its sensitivity in detecting breast cancer, and its ability to identify the size of the breast cancer. Additionally, the negative predictive value of the device will be investigated. This device does not diagnose breast cancer, however it records temperature data and other physiological parameters of the breast, and compares them to a database of patients with known breast health.

The examination process is simple and non-invasive. The patient sits disrobed from the waist up, appropriately positioned in the ergonomic chair with her arms supported at eye level. Temperature controlled air flow is then directed at the breasts for a 4-minute interval while the infrared camera records skin surface cool down at 250 frames per minute. The stored images are fed into proprietary computer software designed to extract specific thermal parameters, including various temperature differences and thermal symmetry measurements. Additionally, the software will focus on areas of the breasts, when compared to its immediate surroundings, that behave abnormally. The program produces a color coded post-processed image of the breasts showing one or more these identified sites, as well as the result of all measured parameters. The combination of these parameters are evaluated for risk in a weighted "evaluation" algorithm, as determined by the information in the database. The results of the digital infrared scan will be correlated with the results of the subsequent breast biopsy.

Selected patients will be required to sign an informed consent form. These patients will have been recommended to have a biopsy, based either on mammography or ultrasound. The patients overall breast density will be noted. Each patient will be "imaged" with the BreastScan IR system, and the raw data stored. The computer will analyze the raw data, and will produce a report showing the results of the test. This report will be stored for use once the results of the patient's biopsy is known.

For each patient, the report will provide an evaluation of "risk" as well as other data that will help localize any suspicious sites. Comparison will be made with actual radiology and pathology results.

If a patient is determined by biopsy to have any form or breast cancer, or atypical hyperplasia, the investigator will examine the BreastScan IR report, and verify that this patient was evaluated as "Risk" (one or more positive risk signs). If sufficient information is provided in the pathology or radiology report to determine the site(s) in the breast, the investigator will again verify that the BreastScan IR report correctly localizes the breast and quadrant of the known cancer. The incidence of incorrect evaluations will be recorded for determination of the system's sensitivity to breast cancer.