A novel functional infrared imaging system coupled with multiparametric computerised analysis for risk assessment of breast cancer.

Abstract

We evaluated a functional three-dimensional (3D) infrared imaging system (3DIRI) coupled with multiparametric computer analysis for risk assessment of breast cancer. The technique provides objective risk assessment for the presence of a malignant tumour based on automated parameters derived from a clinically known training set. Following institutional review board approval, we recruited 434 women for this prospective multicentre trial, including 256 healthy woman undergoing routine screening mammography with BI-RADS-1 results and 178 women with newly diagnosed breast cancer. This was a two-phase study: an initial training and calibration phase, followed by a two-armed blinded evaluation phase (52 healthy and 66 with breast cancer). 3DIRI data sets were acquired using a non-contact, no radiation system. The sensitivity and specificity of functional infrared imaging in providing the correct risk for the presence of breast cancer were 90.9 % and 72.5 %, respectively. The area under the ROC curve was 86 %. Forty-two of the 60 (70 %) cancers in women correctly classified by the system as suspicious were smaller than 20 mm in size. The preliminary blinded results of this novel technology show sufficient performance of functional infrared imaging in providing risk assessment for breast cancer to warrant further clinical studies. • 3D functional infrared imaging (3DIRI) provides new metabolic signatures from breast lesions. • 3DIRI offers high sensitivity for risk assessment of breast cancer. • It also has reasonable specificity. • This initial experience warrants further evaluation in larger clinical trials.