Breast Cancer, Early Detection of Cancer
Conditions
Keywords
Breast cancer, Thermography, Thermalytix, Artificial Intelligence, Machine Learning, Dense Breasts, Breast Density, Mammography, Breast Cancer Screening
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.
Interventions
DIAGNOSTIC_TESTThermalytix
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.
Sponsors
Max Healthcare Insititute Limited
Niramai Health Analytix Private Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 459 |
| Total | 459 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Imaging error; | 64 |
| Overall Study | Lost to Follow-up | 164 |
Baseline characteristics
| Characteristic | Women With no Personal History of Breast Cancer | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 18 Participants | — |
| Age, Categorical Between 18 and 65 years | 441 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment India | 459 participants | — |
| Sex: Female, Male Female | 459 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 459 |
| other Total, other adverse events | 0 / 459 |
| serious Total, serious adverse events | 0 / 459 |
Outcome results
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
Time frame: 2 days
Population: All women who satisfied the inclusion criteria
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women With no Personal History of Breast Cancer | Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix | Sensitivity | 95.24 percentage |
| Women With no Personal History of Breast Cancer | Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix | Specificity | 88.58 percentage |
| Women With no Personal History of Breast Cancer | Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix | NPV | 99.74 percentage |
| Women With no Personal History of Breast Cancer | Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value of Thermalytix | PPV | 28.57 percentage |
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.
Time frame: 2 days
Population: Women with breast density ACR category C or D
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women With no Personal History of Breast Cancer | Sensitivity and Specificity of Thermalytix for Women With Dense Breast Tissue (ACR Category C or D) | Sensitivity | 100 percentage |
| Women With no Personal History of Breast Cancer | Sensitivity and Specificity of Thermalytix for Women With Dense Breast Tissue (ACR Category C or D) | Specificity | 81.65 percentage |
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
Time frame: 2 days
Population: Women with Breast Density ACR category A or B
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women With no Personal History of Breast Cancer | Sensitivity and Specificity of Thermalytix in Women With Breast Density ACR Category A or B | Sensitivity | 90.9 percentage |
| Women With no Personal History of Breast Cancer | Sensitivity and Specificity of Thermalytix in Women With Breast Density ACR Category A or B | Specificity | 92.5 percentage |