๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-08-03

Molecular Breast Imaging (MBI)-Guided Biopsy (NCT07114679)

Molecular Breast Imaging (MBI)-Guided Biopsy Pilot SBIR

๐ŸŸก Not Yet Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Smart Breast Corp.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: University of Texas Southwestern Medical Center โ€” Dallas, Texas

Age range: 21 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • University of Texas Southwestern Medical Center โ€” Dallas, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (724) 584-3266

Email: James.Hugg@SmartBreast.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—