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

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Female subjects equal to and above 18 years
Subjects who are willing to give written informed consent for study participation
Subjects who are ready to comply with the study related visits and procedures

Exclusion Criteria

Subjects who are pregnant
Subjects who are lactating
Subjects who have undergone either lumpectomy or mastectomy
Subjects who have undergone chemotherapy in the last 2 weeks at the time of study enrollment
Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator

Arm && Interventions

Group	Intervention	Description
Women with no personal history of breast cancer	Thermalytix	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix	2 days	To assess the clinical performance of Thermalytix as compared to standard screening modalities. Sensitivity, specificity, positive predictive value and negative predictive value of Thermalytix

Secondary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of Thermalytix for Women With Dense Breast Tissue (ACR Category C or D)	2 days	To assess the influence of patient characteristics (Breast density) on the diagnostic accuracy of Thermalytix.
Sensitivity and Specificity of Thermalytix in Women With Breast Density ACR Category "A" or "B"	2 days	To assess the influence of patient characteristics (Breast density) on the diagnostic accuracy of Thermalytix. Sensitivity and Specificity of Thermalytix in Women with Fatty Breasts - Breast Density ACR category "A" or "B"