Novel Thermal Imaging Technique for Breast Screening

Study Overview
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Brief Summary
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This trial is to study a new breast imaging tool called Thermalytix™. ThermalytixTM is a new radiation-free, automated breast cancer screening technique that uses Artificial Intelligence (AI) over thermal images. Thermal images are heat signatures in our body. This new technique will capture heat signatures in the breast and analyze those images with AI software. This study will evaluate the performance of ThermalytixTM breast imaging against standard imaging modalities, such as mammography and ultrasound.

Official Title
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A Phase II Study to Evaluate Accuracy of ThermalytixTM in Detecting Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Thermalytix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be capable of understanding the investigational nature of the study and all pertinent aspects of the study Be capable of signing and providing written consent in accordance with institutional and federal guidelines Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff Age ≥ 21 years Cohort specific criteria Cohort 1: Be scheduled for biopsy Cohort 2: Had a normal screening mammogram within 3 months of study enrollment Cohort 3: Be scheduled for diagnostic mammogram Cohort 4: History of breast cancer, s/p lumpectomy and be scheduled for routine mammogram Exclusion Criteria: Cohort specific criteria Cohort 1: Previous biopsies in the same or opposite breast within 3 months of study enrollment, prior history of breast cancer, prior history of breast surgeries including implants Cohort 2: prior history of breast surgeries including implants Cohort 3: Already underwent a biopsy in the same or opposite breast within 3 months of study enrollment, prior history of breast cancer, prior history of breast surgeries including implants Cohort 4: surgery <1 year, h/o mastectomy with reconstruction Unable to complete study related procedures

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| Cohort 1: Biopsy<br>Subjects who are scheduled for biopsy will be enrolled. | Device: Thermalytix<br>* One-time Thermal imaging is performed for this cohort.<br>|
| Cohort 2: Screening mammogram<br>Patients who underwent screening mammogram will be enrolled. | Device: Thermalytix<br>* One-time Thermal imaging is performed for this cohort.<br>|
| Cohort 3: Diganostic mammogram<br>Subjects scheduled for diagnostic mammogram will be enrolled. | Device: Thermalytix<br>* One-time Thermal imaging is performed for this cohort.<br>|
| Cohort 4: Prior history of lympectomy, routine mammogram<br>Subjects with prior history of lumpectomy scheduled for their routine mammogram will be enrolled. | Device: Thermalytix<br>* One-time Thermal imaging is performed for this cohort.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of ThermalytixTM in detecting breast cancer | Determine sensitivity and specificity of ThermalytixTM in detecting breast cancer in patients scheduled to undergo breast biopsy (Cohort 1). The sensitivity and specificity will be estimated using 95% exact binomial confidence intervals. The required sample size was determined based on the target sensitivity and specificity, and the resulting confidence intervals. | Through study completion, an average of 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of ThermalytixTM in assessing need for biopsy | To determine accuracy of ThermalytixTM in assessing need for biopsy in patients who are found to have abnormal screening mammogram. Cohort 1 subjects will be used to determine this endpoint. The sensitivity and specificity will be estimated using 95% exact binomial confidence intervals. The required sample size was determined based on the target sensitivity and specificity, and the resulting confidence intervals. | Through study completion, an average of 30 days | 
| Correlate normal screening mammogram results with ThermalytixTM results | To compare ThermalytixTM with screening mammogram in healthy subjects undergoing routine screening. Cohort 2 will be used to assess this endpoint. The specificity will be estimated using 95% exact binomial confidence intervals. The required sample size was determined based on the target specificity, and the resulting confidence intervals. | Through study completion, an average of 30 days | 
| Correlate diagnostic mammogram results with ThermalytixTM results | To compare ThermalytixTM with diagnostic mammogram in subjects who underwent diagnostic mammogram. Cohort 3 will be used for this endpoint. The specificity will be estimated using 95% exact binomial confidence intervals. The required sample size was determined based on the target specificity, and the resulting confidence intervals. | Through study completion, an average of 30 days | 
| Correlate mammogram results with ThermalytixTM results in patients who underwent lumpectomy | To compare ThermalytixTM with mammogram result (screening or diagnostic) in women who underwent lumpectomy. Cohort 4 will be used for this endpoint. The specificity will be estimated using 95% exact binomial confidence intervals. The required sample size was determined based on the target specificity, and the resulting confidence intervals. | Through study completion, an average of 30 days | 
| Report patient experience with ThermalytixTM | Patient experience with ThermalytixTM will be documented via questionnaires. On a scale of 1-5, patients will document their experience during their mammogram and Thermalytix exam; in general, higher values indicate a better outcome. | Through study completion, an average of 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Thermal Imaging, Artificial Intelligence, Breast Imaging