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

NCT ID: NCT06058650

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-26
• Study Completion Date: 2026-08-26

Brief 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.

Detailed 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.

Conditions

Breast Neoplasm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Part I (technetium Tc-99m sestamibi, MBI)

Patients receive technetium Tc-99m sestamibi IV and undergo MBI on study.

Group Type: EXPERIMENTAL

Scintimammography

Intervention Type: RADIATION

Undergo MBI

Technetium Tc-99m Sestamibi

Intervention Type: OTHER

Given IV

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.

Group Type: EXPERIMENTAL

Biopsy of Breast

Intervention Type: PROCEDURE

Undergo biopsy of breast

Medical Device Usage and Evaluation

Intervention Type: OTHER

Utilization of the Stereo Navigator accessory

Scintimammography

Intervention Type: RADIATION

Undergo MBI

Technetium Tc-99m Sestamibi

Intervention Type: OTHER

Given IV

Interventions

Biopsy of Breast

Undergo biopsy of breast

Intervention Type: PROCEDURE

Medical Device Usage and Evaluation

Utilization of the Stereo Navigator accessory

Intervention Type: OTHER

Scintimammography

Undergo MBI

Intervention Type: RADIATION

Technetium Tc-99m Sestamibi

Given IV

Intervention Type: OTHER

Other Intervention Names

Breast Biopsy; Breast-Specific Gamma Imaging; MBI; Miraluma Scan; Miraluma Test; Molecular Breast Imaging; Nuclear Medicine Breast Imaging; sestamibi breast imaging; Sestamibi Scintimammography; Cardiolite; Miraluma; Tc 99m Sestamibi; Tc-99m MIBI; Tc99m Sestamibi; Technetium (99mTc) Sestamibi; 99m Tc-methoxy isobutyl isonitrile

Eligibility Criteria

Inclusion Criteria

• PART I: Women aged 18 years or older
• PART I: If able to become pregnant, negative pregnancy test within 48 hours prior to MBI biopsy procedure
• PART I: Individuals who have previously (within the last 3 years) undergo an MBI study and were found to have at least one breast imaging finding on MBI that was subsequently shown (through additional imaging, biopsy or follow-up) to be benign in nature
• PART I: Individuals who have agreed to participate in the study and who have signed the 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 prior to MBI biopsy procedure
• PART II: Individuals who have previously (within the last 3 years) undergone an MBI study and were found to have at least one breast imaging finding on MBI that was subsequently shown (through additional imaging, biopsy or follow-up) to be benign or probably benign in nature
• PART II: Individuals who had recent conventional imaging work-up including either x-ray mammography, ultrasound, MBI, or MRI of the breast and are found to have at least 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] Breast Imaging Reporting and Data System [BIRADS] 3, or higher) and requiring imaging follow-up or biopsy confirmation
• PART II: Individuals who have agreed to participate in the study and who have signed study-specific informed consent

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
• PART II: Patients with contraindications for core biopsy and other invasive procedures such as blood coagulation disorders, infection, or who are unwilling to discontinue 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katie N. Hunt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Trials Referral Office

Role: CONTACT

mayocliniccancerstudies@mayo.edu

855-776-0015

Facility Contacts

Clinical Trials Referral Office

Role: primary

mayocliniccancerstudies@mayo.edu

855-776-0015

References

Hunt KN, Conners AL, Gray L, Hruska CB, O'Connor MK. Molecular Breast Imaging Biopsy with a Dual-Detector System. Radiol Imaging Cancer. 2024 Jun;6(4):e230186. doi: 10.1148/rycan.230186.

Reference Type: DERIVED

PMID: 38847615 (View on PubMed)

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2023-06047

Identifier Type: REGISTRY

Identifier Source: secondary_id

18-011329

Identifier Type: OTHER

Identifier Source: secondary_id

18-011329

Identifier Type: -

Identifier Source: org_study_id