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
This trial does not accept healthy volunteersQualifiers
dense breasts (BI-RADS C or D) on screening DBT
Disqualifiers
pregnancy
Trial design
Design model
Single group
Treatments tested in this trial
Molecular Breast Imaging
DeviceMBI 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
DeviceTwo 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.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Breast screeningActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Cancer Detection Rate
The number of cancers found by a particular modality compared to the number of women with dense breasts screened by that modality.
Time frame
less than one daySecondary outcomes
1
Concordance Rate
MBI-guided biopsies include an MBI image of the biopsy tissue samples in a Petri dish. Comparison of that image with the pathology report yields concordance.
Time frame
less than a day2
Biopsy Call-Back Rate
The percentage of women with dense breasts screened by a particular modality who have a suspicious lesion on their screening and they require biopsy.
Time frame
less than a day3
Duration of Biopsy
The amount of time that the modality-guided biopsy took to complete.
Time frame
less than a daySponsors and contacts
Click on the lead sponsor to view all of their trials.
Smart Breast Corp.
Lead sponsor
University of Texas, Southwestern Medical Center at Dallas
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: