University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Not Yet Recruiting
NCT Number: NCT07114679
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
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
21 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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 two, and a consensus report will be prepared.
If biopsy is required on the consensus basis of both image sets, then the participant will be randomly assigned to DBT-guided or MBI-guided biopsy. If only one modality has visible lesions that require biopsy, then that modality will be assigned.
The primary outcome measure is Cancer Detection Rate. Secondary outcome measures include Biopsy Callback Rate, Concordance Rate between MBI biopsy sample images and pathology, Time Duration of Biopsy, and Accuracy of Lesion Targeting.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- dense breasts (BI-RADS C or D) on screening DBT
Exclusion criteria
- pregnancy
Treatment and study plan
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.
Other names: MBI
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.
Primary outcomes
-
Cancer Detection Rate
Time frame: less than one day
The number of cancers found by a particular modality compared to the number of women with dense breasts screened by that modality.
Secondary outcomes
-
Concordance Rate
Time frame: less than a day
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.
-
Biopsy Call-Back Rate
Time frame: less than a day
The percentage of women with dense breasts screened by a particular modality who have a suspicious lesion on their screening and they require biopsy.
-
Duration of Biopsy
Time frame: less than a day
The amount of time that the modality-guided biopsy took to complete.
Study contacts
Contact information is provided by the study sponsor or research team.
Bradley E Patt, PhD
CONTACT
James W Hugg, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Smart Breast Corp.
Industry
Collaborators
- National Cancer Institute (NCI)
- University of Texas, Southwestern Medical Center at Dallas
Registry information
Official study title
Molecular Breast Imaging (MBI)-Guided Biopsy Pilot SBIR
Acronym: MBI-GB-Pilot
Important dates
- Study start
- 2027
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Aug 11, 2025
- Registry last updated
- Aug 11, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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