Molecular Breast Imaging (MBI)-Guided Biopsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21+
SponsorSmart Breast Corp.
About this trial
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
Eligibility criteria
Qualifiers
dense breasts (BI-RADS C or D) on screening DBT
Disqualifiers
pregnancy
Trial design
Treatments tested in this trial
- Molecular Breast Imaging
- MBI-guided biopsy
Treatment groups
250 Participants
are divided into 1 treatment groupSponsors and collaborators
Smart Breast Corp.
Lead sponsor
University of Texas, Southwestern Medical Center at Dallas
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov