Using molecular breast imaging to guide breast biopsies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of molecular breast imaging (MBI) in guiding breast biopsies for patients with breast abnormalities. Participants will receive an intravenous injection of technetium Tc-99m sestamibi and undergo MBI to visualize suspicious lesions. If the lesions are detected, a biopsy will be performed using a specialized accessory. The study aims to improve biopsy accuracy compared to traditional methods like ultrasound or mammography.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Katie N. Hunt, M.D. — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.