Molecular Breast Imaging Guidance for Breast Biopsy
This study is looking at a new way to guide breast biopsies using Molecular Breast Imaging (MBI) in patients with breast abnormalities. Currently, biopsies are often guided by ultrasound or mammography, but sometimes the area needing biopsy isn't clearly visible with these methods. MBI, which involves an injection of Technetium Tc-99m Sestamibi (a special dye) and a type of scan called scintimammography, may help doctors see these areas better. This trial will test if a new high-resolution MBI system and a device called the Stereo Navigator accessory can accurately guide a breast biopsy. The study aims to see how well this MBI-guided biopsy works to get a sample from the correct part of the breast. It is open to women aged 18 and older.
- Study design
- This is an interventional study with an unclear status, planning to enroll 70 participants. It is structured in two parts, with some participants undergoing MBI and others undergoing MBI followed by a biopsy guided by MBI.
- What's involved
- You would receive an intravenous (IV) injection of Technetium Tc-99m Sestamibi and undergo a Molecular Breast Imaging (MBI) scan. If your breast lesion is seen on MBI, you might also have a breast biopsy using the Stereo Navigator accessory.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the study procedures, you may be asked to have follow-up visits between 3 and 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Katie N. Hunt, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Validation of timeframeBaseline
Time from injection of the technetium Tc-99m sestamibi to identification of the appropriate needle guide hole will be reviewed to determine if and where any improvements in workflow can be made to reduce the overall procedure time for patients.
- Change in image of lesionBaseline; Up to 6 months
The coordinates of the lesion of interest on the high resolution MBI image will be recorded. The guidance procedure will be considered successful if 1) the pre and post images of the lesion demonstrated one of the following: decreased in size, central or eccentric defect where sampled, or decrease in intensity, or 2) pathology results demonstrate malignancy or a specific benign concordant result.
- Accuracy of depth estimation by difference in attenuation from opposing viewsBaseline; Up to 6 months
For each patient in whom pathology confirms successful sampling of the lesion seen on high-resolution molecular breast imaging (MBI), the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.
- Accuracy of depth estimation by difference in apparent lesion sizeBaseline; Up to 6 months
For each patient in whom pathology confirms successful sampling of the lesion seen on MBI, the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.
- Accuracy of depth estimation by triangulationBaseline; Up to 6 months
For each patient in whom pathology confirms successful sampling of the lesion seen on MBI, the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.