NCT06058650

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

Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2021-08-26
• Primary completion: 2026-08-26
• Completion: 2026-08-26
• First posted: 2023-09-28
• Last updated: 2025-09-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study