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Molecular Breast Imaging (MBI)-Guided Biopsy

NCT07114679 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-08-11

No results posted yet for this study

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

Conditions

  • Breast Cancer Detection
  • Breast Neoplasm
  • Molecular Imaging
  • Biopsy
  • Dense Breasts

Interventions

DEVICE

Molecular 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.

DEVICE

MBI-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.

Sponsors & Collaborators

  • University of Texas, Southwestern Medical Center at Dallas

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Smart Breast Corp.

    lead INDUSTRY

Principal Investigators

  • James W Hugg, PhD · Smart Breast Corp.

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-06-30
Primary Completion
2028-02-29
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07114679 on ClinicalTrials.gov