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

NCT ID: NCT04688086

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 687 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-15
• Study Completion Date: 2020-01-30

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.

Conditions

Breast Cancer; Early Detection of Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women with no personal history of breast cancer

Women who came in for a breast mammography between ages 30 and 80 years were invited to take part in the study. All the women included in the study underwent breast cancer screening first by Thermalytix, the AI-based thermal imaging test, followed by mammography.

Thermalytix

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Female subjects equal to and above 18 years

2. Subjects who are willing to give written informed consent for study participation

3. Subjects who are ready to comply with the study related visits and procedures

Exclusion Criteria

1. Subjects who are pregnant

2. Subjects who are lactating

3. Subjects who have undergone either lumpectomy or mastectomy

4. Subjects who have undergone chemotherapy in the last 2 weeks at the time of study enrollment

5. Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Max Healthcare Insititute Limited

OTHER

Sponsor Role: collaborator

Niramai Health Analytix Private Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richa Bansal, MD

Role: PRINCIPAL_INVESTIGATOR

Max Healthcare Insititute Limited

Locations

Max Healthcare Insititute Limited

New Delhi, , India

Countries

India

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NIR-THERMA-02

Identifier Type: -

Identifier Source: org_study_id