Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis
Status unconfirmed
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT05369546
- Run by
- University of Hawaii
- People needed
- 600
- Starts
- 2022-08-01
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2023-02-02
Who can join
Age: 20 and older, up to 85. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.).
Where it is running
- H. Lee Moffitt Cancer Center & Research Institute, Inc. — Tampa, Florida, United States (enrolling)
- Hawaii Radiology Associates, LTD (East Hawaii Women's Imaging Center) — Hilo, Hawaii, United States (enrolling)
- The Queen's Medical Center — Honolulu, Hawaii, United States (enrolling)
Full record on ClinicalTrials.gov
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