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| Name | Class |
|---|---|
| Max Healthcare Insititute Limited | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermalytix | 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. |
| 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. Sensitivity, specificity, positive predictive value and negative predictive value of Thermalytix | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of Thermalytix for Women With Dense Breast Tissue (ACR Category C or D) | To assess the influence of patient characteristics (Breast density) on the diagnostic accuracy of Thermalytix. | 2 days |
| Sensitivity and Specificity of Thermalytix in Women With Breast Density ACR Category "A" or "B" |
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Inclusion Criteria:
Exclusion Criteria:
The participant eligibility is based on self-representation of gender identity
Women who came in for a breast mammography at Max Super Speciality Hospital, Saket were invited to take part in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Richa Bansal, MD | Max Healthcare Insititute Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Max Healthcare Insititute Limited | New Delhi | 110017 | India |
The study protocol and clinical study report will be made available to investigators from academic institutions for non-commercial use and whose proposed use of the data has been approved by an independent review committee. The individual participant data would be shared for meta-analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Women with no personal history of breast cancer
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix | To assess the clinical performance of Thermalytix as compared to standard screening modalities. Sensitivity, specificity, positive predictive value and negative predictive value of Thermalytix | All women who satisfied the inclusion criteria | Posted | Number | 95% Confidence Interval | percentage | 2 days |
|
Adverse event data was collected over a period of one year post study. No adverse events were reported during this period Each participant would require less than a day to assess if there was an adverse event.
Self reported events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sathiakar Collison | NIRAMAI Health Analytix Private Limited | +919810823838 | sathiakar.collison@niramai.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2020 | Jul 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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" |
| 2 days |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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|
| Secondary | Sensitivity and Specificity of Thermalytix for Women With Dense Breast Tissue (ACR Category C or D) | To assess the influence of patient characteristics (Breast density) on the diagnostic accuracy of Thermalytix. | Women with breast density ACR category C or D | Posted | Number | 95% Confidence Interval | percentage | 2 days |
|
|
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| Secondary | Sensitivity and Specificity of Thermalytix in Women With Breast Density ACR Category "A" or "B" | 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" | Women with Breast Density ACR category "A" or "B" | Posted | Number | 95% Confidence Interval | percentage | 2 days |
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| 0 |
| 459 |
| 0 |
| 459 |
| 0 |
| 459 |
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| D017437 |
| Skin and Connective Tissue Diseases |