MedTrace Logo

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

NCT04688086 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 687

Last updated 2024-10-17

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Max Healthcare Insititute Limited

    collaborator OTHER

  • Niramai Health Analytix Private Limited

    lead INDUSTRY

Principal Investigators

  • Richa Bansal, MD · Max Healthcare Insititute Limited

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-15
Primary Completion
2020-01-06
Completion
2020-01-30

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04688086 on ClinicalTrials.gov