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

Niramai Health Analytix

Status: Completed

Conditions: Early Detection of Cancer; Breast Cancer

Treatments: Diagnostic Test: Thermalytix

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04688086

NIR-THERMA-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 687 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

687 participants in 1 patient group

Women with no personal history of breast cancer

Description:

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.

Treatment:

Diagnostic Test: Thermalytix