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Molecular Breast Imaging (MBI)-Guided Biopsy
Sponsor: Smart Breast Corp.
Summary
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
Official title: Molecular Breast Imaging (MBI)-Guided Biopsy Pilot SBIR
Key Details
Gender
FEMALE
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2027-06
Completion Date
2028-06
Last Updated
2025-08-11
Healthy Volunteers
No
Interventions
Molecular Breast Imaging
MBI is a molecular imaging (nuclear medicine) technique using a low dose i.v. radiopharmaceutical injection and solid-state gamma cameras to image the breast, where cancer mitochondria avidly take up the radiopharmaceutical.
MBI-guided biopsy
Two stereotactic MBI views of the breast produce a precise 3D location for each lesion targeted for biopsy. A vacuum-assisted core biopsy needle is guided to the lesion position.
Locations (1)
University of Texas Southwestern Medical Center
Dallas, Texas, United States