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

Last updated: March 14, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Treatment

Technetium Tc-99m Sestamibi

Biopsy of Breast

Medical Device Usage and Evaluation

Clinical Study ID

NCT06058650
18-011329
18-011329
NCI-2023-06047
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • PART I: Women aged 18 years or older

  • PART I: If able to become pregnant, negative pregnancy test within 48 hours prior toMBI biopsy procedure

  • PART I: Individuals who have previously (within the last 3 years) undergo an MBIstudy and were found to have at least one breast imaging finding on MBI that wassubsequently shown (through additional imaging, biopsy or follow-up) to be benign innature

  • PART I: Individuals who have agreed to participate in the study and who have signedthe study-specific informed consent

  • PART II: Women aged 18 years or older

  • PART II: If able to become pregnant, negative pregnancy test within 48 hours priorto MBI biopsy procedure

  • PART II: Individuals who have previously (within the last 3 years) undergone an MBIstudy and were found to have at least one breast imaging finding on MBI that wassubsequently shown (through additional imaging, biopsy or follow-up) to be benign orprobably benign in nature

  • PART II: Individuals who had recent conventional imaging work-up including eitherx-ray mammography, ultrasound, MBI, or MRI of the breast and are found to have atleast one breast imaging finding for which biopsy is required or recommended,specifically:

  • Individuals who have a breast abnormality(ies) on imaging with mammography,ultrasound, MBI, or MRI (as per American College of Radiology [ACR] BreastImaging Reporting and Data System [BIRADS] 3, or higher) and requiring imagingfollow-up or biopsy confirmation

  • PART II: Individuals who have agreed to participate in the study and who have signedstudy-specific informed consent

Exclusion

Exclusion Criteria:

  • PART I: Women who are pregnant

  • PART I: Women who are currently lactating or discontinued breastfeeding < 2 monthsprior 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 monthsprior to the study

  • PART II: Age less than 18 years

  • PART II: Women with breast implant(s) in the breast containing the lesion ofinterest

  • PART II: Women who have recently (within the last 3 months) undergone biopsy of thebreast finding

  • PART II: Women who are scheduled for a sentinel node procedure using radioactiveTc-99m within 24 hours of MBI-guided biopsy

  • PART II: Patients with contraindications for core biopsy and other invasiveprocedures such as blood coagulation disorders, infection, or who are unwilling todiscontinue use of anticoagulant medication prior to the procedure

  • PART II: Inability to provide informed consent

  • PART II: Women who have had surgery on the study breast(s) within the past 12 months

Study Design

Total Participants: 70
Treatment Group(s): 4
Primary Treatment: Technetium Tc-99m Sestamibi
Phase:
Study Start date:
August 26, 2021
Estimated Completion Date:
August 26, 2026

Study Description

PRIMARY OBJECTIVE:

I. To evaluate a methodology for MBI-guided biopsy of suspicious breast lesions.

OUTLINE: Patients are assigned to 1 of 2 study parts.

PART I: Patients receive technetium Tc-99m sestamibi intravenously (IV) and undergo MBI on study.

PART II: 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.

After completion of study intervention, patients may be asked to follow up at 3-6 months.

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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