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

Breast Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Early Detection of Cancer

• NCT number: NCT04688086
• Study type: Observational
• Source: Niramai Health Analytix Private Limited
• Status: Completed
• Start date: December 15, 2018
• Completion date: January 30, 2020