About this trial
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 and increase biopsy yield. To do this, the investigators have developed an innovative way to use FDA-approved breast imaging protocols to acquire multispectral images to measure the composition of suspicious breast lesions. The central hypothesis is that breast tissue composition in combination with analysis of morphological and textural tissue characteristics on digital breast tomosynthesis (DBT) imaging will yield significantly higher breast cancer specificity than conventional interpretation of DBT alone.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.).
Trial design
Treatments tested in this trial
- q3CB
Treatment groups
Sponsors and collaborators
University of Hawaii
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborator
Queen's Medical Center
Collaborator
Hawaii Radiologic Associates, Ltd.
Collaborator