Breast Cancer Clinical Trial
Novel Thermal Imaging Technique for Breast Screening
Summary
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.
Eligibility Criteria
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
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There is 1 Location for this study
Tucson Arizona, 85721, United States
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