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.
Study Type
OBSERVATIONAL
Enrollment
115
One-time Thermal imaging is performed for this cohort.
University of Arizona Cancer Center
Tucson, Arizona, United States
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.
Time frame: Through study completion, an average of 30 days
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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 30 days
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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.
Time frame: 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.
Time frame: Through study completion, an average of 30 days