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

Launched by MAYO CLINIC · Sep 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new technique called molecular breast imaging (MBI) to help doctors collect breast tissue samples (biopsies) more accurately from women with breast abnormalities. Unlike traditional methods that use ultrasound or mammography, MBI may provide better images of certain breast tumors that are hard to see. The goal is to see if this advanced imaging can lead to more precise biopsies, ensuring that the correct area of the breast is targeted for testing.

To participate in this trial, women must be at least 18 years old and have had a recent breast imaging study that showed an abnormality requiring a biopsy. They should also not be pregnant or breastfeeding. If you choose to participate, you will undergo the MBI procedure, which aims to guide the biopsy more effectively. Your involvement will help researchers understand how MBI can improve breast cancer detection and care for patients like you.

Gender

FEMALE

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