Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities
Mayo Clinic
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 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.
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 sestamibi intravenously (IV) and undergo MBI on study. PART II: Patients receive technetium Tc-99m sestamibi IV and undergo MBI. Patients whose breast lesions of interest are visualized on MBI then undergo breast biopsy using the Stereo Navigator accessory. After completion of study intervention, patients may be asked to follow up at 3-6 months.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- ProcedureBiopsy of Breast
Undergo biopsy of breast
- OtherMedical Device Usage and Evaluation
Utilization of the Stereo Navigator accessory
- RadiationScintimammography
Undergo MBI
- OtherTechnetium Tc-99m Sestamibi
Given IV
Location
- Mayo Clinic in RochesterRochester, Minnesota