Molecular Breast Imaging (MBI)-Guided Biopsy

The goal of this pilot clinical trial is to demonstrate supplemental screening MBI (molecular breast imaging) in women with dense breasts. The main questions it aims to answer are: * Does screening MBI find more cancer than screening DBT (3D mammography, digital breast tomosynthesis? * Does screening MBI result in more call-backs for biopsy than DBT? * How well does MBI-guided biopsy conform with pathology reports? Researchers will compare screening MBI to screening DBT to see if MBI is more sensitive to detecting cancer in women with dense breasts. Participants will * Receive both screening DBT and screening MBI * Receive either DBT-guided or MBI-guided biopsy (randomly assigned), if required by the screening images

NCT Number	NCT07114679
Lead Sponsor	Smart Breast Corp. Collaborators: University of Texas, Southwestern Medical Center at Dallas, National Cancer Institute (NCI)
Conditions	Breast Cancer Detection, Breast Neoplasm, Molecular Imaging, Biopsy, Dense Breasts
Enrollment	250 participants
Start Date	2027-06
Primary Completion	2028-02 (estimated)
Study Completion	2028-06 (estimated)
Updated on ClinicalTrials.gov	2025-08-11