Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-28 @ 2:02 PM
Study NCT ID:
NCT06058650
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2023-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: