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Not yet recruiting Not applicable Interventional

Molecular Breast Imaging (MBI)-Guided Biopsy

ClinicalTrials.gov ID: NCT07114679

Public ClinicalTrials.gov record NCT07114679. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 12:03 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Molecular Breast Imaging (MBI)-Guided Biopsy Pilot SBIR

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT07114679
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Smart Breast Corp.
Industry
Enrollment
250 participants

Conditions and interventions

Eligibility (public fields only)

Age range
21 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2027
Primary completion
Jan 31, 2028
Completion
May 31, 2028
Last update posted
Aug 10, 2025

2027 – 2028

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Texas Southwestern Medical Center Dallas Texas 75390

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07114679, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 10, 2025 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07114679 live on ClinicalTrials.gov.

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