Status:
RECRUITING
Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities
Lead Sponsor:
Mayo Clinic
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 26 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06058650
Start Date
August 26 2021
End Date
August 26 2026
Last Update
September 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905