Spots Global Cancer Trial Database for A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers

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Trial Identification

Brief Title: A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers

Official Title: A Prospective Study to Evaluate the Effectiveness of Thermalytix (AI-based Thermographic Solution Developed by Niramai) for Breast Cancer Screening as Compared to Standard Screening Modalities for Breast Cancer

Study ID: NCT04688086

Conditions

Breast Cancer

Early Detection of Cancer

Interventions

Thermalytix

Study Description

Brief Summary: The purpose of this study is to determine the clinical performance of AI-based Thermalytix with the current standard-of-care diagnostic modalities in women.

Detailed Description: While mammography is the most accepted breast cancer screening test, it is less sensitive in women with dense breast tissue, who have a four fold high risk for developing breast cancer. Thermalytix is a novel automated breast cancer screening solution that uses artificial intelligence (AI) over thermal images to detect and localise breast cancer lesions in women. In this study the performance of Thermalytix over mammography is evaluated in women with dense and non-dense breast tissue who presented for a health check-up at a hospital. All women underwent Thermalytix and mammography, and participants who were reported as positive on either test were recommended for further investigations. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated across age-groups, menopausal status, and breast densities against the current standard-of-care diagnostic modalities.