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PI has left the institution (University of Arizona Cancer Center).
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This trial is to study a new breast imaging tool called Thermalytixâ„¢. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Biopsy | Subjects who are scheduled for biopsy will be enrolled. |
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| Cohort 2: Screening mammogram | Patients who underwent screening mammogram will be enrolled. |
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| Cohort 3: Diganostic mammogram | Subjects scheduled for diagnostic mammogram will be enrolled. |
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| Cohort 4: Prior history of lympectomy, routine mammogram | Subjects with prior history of lumpectomy scheduled for their routine mammogram will be enrolled. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermalytix | Device | One-time Thermal imaging is performed for this cohort. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for breast biopsy or mammogram
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| Name | Affiliation | Role |
|---|---|---|
| Pavani Chalasani, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85721 | United States |
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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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| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |