A Phase II Study to Evaluate Accuracy of ThermalytixTM in Detecting Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Arizona
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Sensitivity and specificity of ThermalytixTM in detecting breast cancer
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Sensitivity and specificity of ThermalytixTM in detecting breast cancer
Time Frame: 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 Outcomes
- Correlate normal screening mammogram results with ThermalytixTM results(Through study completion, an average of 30 days)
- Sensitivity and specificity of ThermalytixTM in assessing need for biopsy(Through study completion, an average of 30 days)
- Report patient experience with ThermalytixTM(Through study completion, an average of 30 days)
- Correlate diagnostic mammogram results with ThermalytixTM results(Through study completion, an average of 30 days)
- Correlate mammogram results with ThermalytixTM results in patients who underwent lumpectomy(Through study completion, an average of 30 days)