Breast Imaging as Part of Breast Cancer Screening Using AI-Powered Thermal Imaging Technology

Breast cancer (mammary carcinoma) is the most common cancer in women. The earlier the cancer is detected, the better the chances of successful treatment. The standard screening methods include imaging tests such as mammography, ultrasound, and magnetic resonance imaging (MRI). However, these standard methods for breast cancer diagnosis have limitations and risks, such as radiation exposure, high false-positive rates, and high costs. The ThermoBreast study is investigating an alternative approach that uses a high-resolution infrared camera to measure the external skin temperature of the breast—non-invasively and without radiation (thermography). Artificial intelligence (AI) searches for typical heat patterns that may result from altered blood flow and metabolism in tumors. For example, a tumor often exhibits increased blood flow. Thus, thermography could serve as a complementary procedure, particularly in cases of dense breast tissue or for close monitoring. However, it does not replace a medical examination.

The goal of the ThermoBreast study is to investigate whether a thermal image of the breast, analyzed using artificial intelligence (AI), can detect and rule out breast cancer just as reliably—or even more reliably—than current standard procedures such as mammography or ultrasound. To this end, the women are divided into three groups (cohorts): the screening cohort, the high-risk screening cohort, and the diagnostic cohort. The first group consists of women between the ages of 40 and 74 who are invited to undergo a mammogram or tomosynthesis (3D mammography) as part of routine breast cancer screening. The second group consists of women aged 18 and older who have an increased risk of breast cancer—for example, due to a genetic predisposition such as a BRCA mutation or a family history of the disease—and who therefore undergo more frequent screening. The third group includes women aged 18 and older who have previously had breast cancer and are currently in follow-up care, who notice current symptoms such as a palpable lump or nipple discharge, or whose previous examinations have shown abnormal results. All women will then receive a ThermoBreast scan in addition to their regular, guideline-based diagnostic or screening examination. The ThermoBreast results will not be disclosed to the women or their treating physicians so that decisions are made solely based on the standard examinations. Two study visits are scheduled (information/consent and the ThermoBreast questionnaire in conjunction with routine diagnostic testing; a subsequent follow-up appointment is for the routine checkup only). The key factors are the detection rate for breast cancer and the reliability in ruling out the disease compared to routine procedures and histological examination, if performed.

Women 18 years of age or older who are undergoing a routine breast cancer screening or a diagnostic examination are eligible to participate. Exclusion criteria include pregnancy/breastfeeding, breast surgery (breast-conserving surgery/mastectomy) within the last 4 months, cancer treatment (chemotherapy, initiation of anti-hormone therapy, radiation therapy, surgery) within the last 4 months, and a biopsy within the last 2 months.