Molecular Breast Imaging (MBI)-Guided Biopsy

NCT07114679 | Not Yet Recruiting FDA Device

• 1 other identifier: MBI_Biopsy_Pilot_SBIR
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

screening; crossover; single-group; pilot; biopsy; randomized assignment; dense breasts; MBI; molecular imaging

Outcome Measures

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.

  less than one day

Secondary Outcomes (3)

• Concordance Rate

  less than a day

• Biopsy Call-Back Rate

  less than a day

• Duration of Biopsy

  less than a day

Study Arms (1)

Breast screening

ACTIVE COMPARATOR

Screening DBT and screening MBI are compared in women with dense breasts. Then, DBT-guided biopsy and MBI-guided biopsy are compared.

Device: Molecular Breast Imaging; Device: MBI-guided biopsy

Interventions

Molecular Breast Imaging DEVICE

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.

Also known as: MBI

Breast screening

MBI-guided biopsy DEVICE

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.

Breast screening

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• dense breasts (BI-RADS C or D) on screening DBT

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• Smart Breast Corp.: lead
• University of Texas, Southwestern Medical Center at Dallas: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• James W Hugg, PhD

  Smart Breast Corp.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James W Hugg, PhD

CONTACT

724-584-3266; James.Hugg@SmartBreast.com

Bradley E Patt, PhD

CONTACT

818-645-4081; Brad.Patt@SmartBreast.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: After MBI-guided biopsy samples are placed sequentially in a Petri dish, an MBI image of the samples is taken. This image will be compared to the pathology report for concordance. The Outcomes Assessor will be blinded to patient ID and medical records. Similarly, the pathology report and screening DBT images will be compared.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Every participant (dense breast woman) will receive both screening DBT and screening MBI (crossover). If biopsy is required, participant will be randomly assigned to either DBT-guided or MBI-guided biopsy.

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)