Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis

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.

NCT Number	NCT05369546
Lead Sponsor	University of Hawaii Collaborators: H. Lee Moffitt Cancer Center and Research Institute, Queen's Medical Center, Hawaii Radiologic Associates, Ltd.
Conditions	Breast Cancer
Enrollment	600 participants
Start Date	2022-08-01
Primary Completion	2025-07 (estimated)
Study Completion	2026-07 (estimated)
Updated on ClinicalTrials.gov	2023-02-02