MBI-Guided Biopsy for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulant medication (blood thinners), you must be willing to stop using them before the procedure.
What data supports the effectiveness of the treatment Molecular Breast Imaging (MBI) for breast cancer?
Molecular Breast Imaging (MBI) is effective in detecting additional hidden breast cancers in 9% of women with newly diagnosed breast cancer and has a high sensitivity for detecting high-risk lesions, identifying 98% of invasive breast cancer and 91% of ductal carcinoma in situ. It is also useful for women with dense breasts, detecting hidden cancer in up to 16.5 per 1000 women, and influences surgical management in nearly a quarter of women with newly diagnosed breast cancer.12345
Is Molecular Breast Imaging (MBI) safe for humans?
How is the treatment Molecular Breast Imaging (MBI) different from other breast cancer treatments?
Molecular Breast Imaging (MBI) is unique because it uses a special type of camera to detect breast cancer based on how the tissue functions, rather than just its structure, which is how traditional mammograms and ultrasounds work. This allows MBI to find cancers that might be hidden in dense breast tissue and can guide biopsies of suspicious areas that other methods might miss.12378
What is the purpose of this trial?
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.
Research Team
Katie N. Hunt, M.D.
Principal Investigator
Mayo Clinic in Rochester
Eligibility Criteria
This trial is for women aged 18 or older who have had a benign breast abnormality detected by MBI in the past 3 years. They must not be pregnant, breastfeeding within the last 2 months, or have had recent breast surgery. Participants need a negative pregnancy test before biopsy if they can become pregnant and must consent to join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Part I: MBI Imaging
Patients receive technetium Tc-99m sestamibi IV and undergo MBI on study
Part II: MBI Imaging and Biopsy
Patients receive technetium Tc-99m sestamibi IV and undergo MBI. If lesions are visualized, a biopsy is performed using the Stereo Navigator accessory
Follow-up
Participants are monitored for safety and effectiveness after the biopsy procedure
Treatment Details
Interventions
- Molecular Breast Imaging
Molecular Breast Imaging is already approved in United States, European Union for the following indications:
- Breast cancer screening
- Breast biopsy guidance
- Assessment of breast cancer treatment response
- Supplemental breast cancer screening in dense breast tissue
- Investigation of breast abnormalities
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor