Breast Cancer
Conditions
Keywords
Breast Cancer, Thermal Imaging, Artificial Intelligence, Breast Imaging
Brief summary
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.
Interventions
DEVICEThermalytix
One-time Thermal imaging is performed for this cohort.
Sponsors
University of Arizona
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of ThermalytixTM in detecting breast cancer | Through study completion, an average of 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of ThermalytixTM in assessing need for biopsy | Through study completion, an average of 30 days | 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. |
| Correlate normal screening mammogram results with ThermalytixTM results | Through study completion, an average of 30 days | 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. |
| Correlate diagnostic mammogram results with ThermalytixTM results | Through study completion, an average of 30 days | 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. |
| Correlate mammogram results with ThermalytixTM results in patients who underwent lumpectomy | Through study completion, an average of 30 days | 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. |
| Report patient experience with ThermalytixTM | Through study completion, an average of 30 days | 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. |
Countries
United States
Outcome results
None listed