NCT04688086

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

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
• Phase: —
• Study type: Observational
• Enrollment: 687 (actual)
• Sponsor: Niramai Health Analytix Private Limited · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer
• Early Detection of Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Thermalytix	Thermalytix is an Artificial intelligence based automated breast screening solution that analyzes thermal distribution on the breast to generate a breast health score automatically. Thermal imaging was performed by a trained technician to capture thermal images of the participant in five views. These thermal images were uploaded to Thermalytix software on the cloud where it was automatically analyzed by AI-based Thermalytix computer-aided detection (CADe) engine. This CADe engine analyzes uploaded thermal images and outputs an interpretation report for each participant with quantitative scores corresponding to computed probability of malignancy based on the structural, vascular, areolar, thermal properties of the observed abnormality. Thermalytix also generates annotated images with markings of abnormal regions and an overall Thermalytix score suggesting likelihood of breast malignancy. The locked AI model Thermalytix algorithm version 3, dated December 2018 was used for the analysis.

Timeline

• Start date: 2018-12-15
• Primary completion: 2020-01-06
• Completion: 2020-01-30
• First posted: 2020-12-29
• Last updated: 2024-10-17
• Results posted: 2024-10-17

Locations

1 site across 1 country: India