๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-09-29

Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities (NCT06058650)

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿฉบ Clinical Procedure Protocol Sponsor: Mayo Clinic

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

This clinical trial tests how well molecular breast imaging (MBI) works to guide the collection of a breast biopsy in patients with a breast abnormality. Currently, a biopsy is often guided by either ultrasound or mammography in order to ensure that a sample of the correct part of the breast is taken. Sometimes a lesion or part of the lesion cannot be seen on ultrasound or mammography, and, therefore, a biopsy guided with ultrasound or mammography may not be always be accurate. Studies have shown that high resolution MBI may have potential to improve the detection of some breast tumors. This trial uses a new high-resolution MBI system that may help perform a biopsy using MBI.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (15 items).

Location: Mayo Clinic in Rochester โ€” Rochester, Minnesota

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

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • PART I: Women who are pregnant
  • PART I: Women who are currently lactating or discontinued breastfeeding \< 2 months prior to the study
  • PART I: Age less than 18 years
  • PART I: Women with breast implant(s) in the breast containing the lesion of interest
  • PART I: Inability to provide informed consent
  • PART II: Women who are pregnant
  • PART II: Women who are currently lactating or discontinued breastfeeding \< 2 months prior to the study
  • PART II: Age less than 18 years
  • PART II: Women with breast implant(s) in the breast containing the lesion of interest
  • PART II: Women who have recently (within the last 3 months) undergone biopsy of the breast finding
  • PART II: Women who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of MBI-guided biopsy

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

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

  • Mayo Clinic in Rochester โ€” Rochester, Minnesota

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›๏ธ View Official NIH Record โ†—