Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06058650
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy of Breast — PROCEDURE
    Undergo biopsy of breast
  • Medical Device Usage and Evaluation — OTHER
    Utilization of the Stereo Navigator accessory
  • Scintimammography — RADIATION
    Undergo MBI
  • Technetium Tc-99m Sestamibi — OTHER
    Given IV

Study Details

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.

Key Dates

Start date
Aug 26, 2021
Status verified
Sep 2025
Primary completion
Aug 26, 2026
Completion
Aug 26, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Part I (technetium Tc-99m sestamibi, MBI)
    Patients receive technetium Tc-99m sestamibi IV and undergo MBI on study.
  • Experimental: Part II (technetium Tc-99m sestamibi, MBI, biopsy)
    Patients receive technetium Tc-99m sestamibi IV and undergo MBI. Patients whose breast lesions of interest are visualized on MBI then undergo breast biopsy using the Stereo Navigator accessory.

Primary Outcome Measure

Validation of timeframe [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Katie N. Hunt, M.D. (PRINCIPAL_INVESTIGATOR)

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