Status:
RECRUITING
Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis
Lead Sponsor:
University of Hawaii
Collaborating Sponsors:
H. Lee Moffitt Cancer Center and Research Institute
Queen's Medical Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
20-85 years
Brief Summary
The objective is to better identify suspicious breast lesions that need to be biopsied for malignancy in women currently recommended for biopsy. The long-term goal is to reduce unnecessary biopsies an...
Detailed Description
Women with dense breast have not been shown to benefit by increased cancer detection of volumetric digital breast tomosynthesis (DBT) but may benefit by lower recall rates. DBT screening biopsy rates ...
Eligibility Criteria
Inclusion
- Had a recent diagnostic mammogram with a BI-RADS diagnostic score 4 or 5 assigned by a radiologist (BIRADS are standardized mammography assessment categories: 4 is for "Suspicious abnormality", 5 is for "Highly suggestive of malignancy".
- Have not had biopsy
Exclusion
- Pregnant or breast feeding
- History of breast cancer or a mastectomy (removal of the breast) with Systemic Therapy (ex. Chemotherapy, hormones and hormone inhibitors, etc.).
Key Trial Info
Start Date :
August 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05369546
Start Date
August 1 2022
End Date
July 1 2026
Last Update
February 2 2023
Active Locations (3)
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1
H. Lee Moffitt Cancer Center & Research Institute, Inc.
Tampa, Florida, United States, 33612
2
Hawaii Radiology Associates, LTD (East Hawaii Women's Imaging Center)
Hilo, Hawaii, United States, 96720
3
The Queen's Medical Center
Honolulu, Hawaii, United States, 96822