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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer, Early Detection of Cancer

Intervention / Treatment
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* Diagnostic Test: Thermalytix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with no personal history of breast cancer<br>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. | Diagnostic Test: Thermalytix<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, positive predictive value and negative predictive value of Thermalytix | To assess the clinical performance of Thermalytix as compared to standard screening modalities | End of study (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of Thermalytix for different patient characteristics | To assess the influence of patient characteristics, such as age, menopausal status, breast density on the diagnostic accuracy of Thermalytix. The patient characteristics will be collected through a questionnaire. | End of study (1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Thermography, Thermalytix, Artificial Intelligence, Machine Learning, Dense Breasts, Breast Density, Mammography, Breast Cancer Screening