Molecular Breast Imaging (MBI)-Guided Biopsy Pilot SBIR
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
Description
This is a pilot single-group crossover screening clinical trial comparing screening MBI (molecular breast imaging) to screening DBT (3D mammography, digital breast tomosynthesis. Women who have recently completed their annual screening DBT will be assessed for breast density. If they have BI-RADS density C or D (dense breasts), they are eligible for this study. After consent, participants will receive a supplemental screening MBI (crossover from DBT). Both screenings will be read while blinded to knowledge of the other. After independent reporting, a Conciliation Conference will compare the tw…
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * dense breasts (BI-RADS C or D) on screening DBT Exclusion Criteria: * pregnancy
Interventions
- DeviceMolecular 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.
- DeviceMBI-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.
Location
- University of Texas Southwestern Medical CenterDallas, Texas