Novel Thermal Imaging Technique for Breast Screening

A Phase II Study to Evaluate Accuracy of ThermalytixTM in Detecting Breast Cancer

This trial is to study a new breast imaging tool called Thermalytix™. ThermalytixTM is a new radiation-free, automated breast cancer screening technique that uses Artificial Intelligence (AI) over thermal images. Thermal images are heat signatures in our body. This new technique will capture heat signatures in the breast and analyze those images with AI software. This study will evaluate the performance of ThermalytixTM breast imaging against standard imaging modalities, such as mammography and ultrasound.

Inclusion Criteria:

• Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
• Be capable of signing and providing written consent in accordance with institutional and federal guidelines
• Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
• Age ≥ 21 years
• Cohort specific criteria
• Cohort 1: Be scheduled for biopsy
• Cohort 2: Had a normal screening mammogram within 3 months of study enrollment
• Cohort 3: Be scheduled for diagnostic mammogram
• Cohort 4: History of breast cancer, s/p lumpectomy and be scheduled for routine mammogram

Exclusion Criteria:

• Cohort specific criteria
• Cohort 1: Previous biopsies in the same or opposite breast within 3 months of study enrollment, prior history of breast cancer, prior history of breast surgeries including implants
• Cohort 2: prior history of breast surgeries including implants
• Cohort 3: Already underwent a biopsy in the same or opposite breast within 3 months of study enrollment, prior history of breast cancer, prior history of breast surgeries including implants
• Cohort 4: surgery <1 year, h/o mastectomy with reconstruction
• Unable to complete study related procedures