Using molecular breast imaging to guide breast biopsies
Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities
NA · Mayo Clinic · NCT06058650
This study is testing whether a new imaging technique can help doctors find and biopsy suspicious breast lumps more accurately than standard methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06058650 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with suspicious breast lesions who have previously undergone MBI.
Not a fit: Patients who do not have suspicious breast lesions or those who have not undergone prior MBI studies may not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate breast biopsies and better detection of breast tumors.
How similar studies have performed: Previous studies have indicated that high-resolution MBI may improve tumor detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Neoplasm