Back to resultsMolecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities
Primary Purpose
Breast Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biopsy of Breast
Medical Device Usage and Evaluation
Scintimammography
Technetium Tc-99m Sestamibi
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Neoplasm
Eligibility 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
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part I (technetium Tc-99m sestamibi, MBI)
Part II (technetium Tc-99m sestamibi, MBI, biopsy)
Arm Description
Patients receive technetium Tc-99m sestamibi IV and undergo MBI on study.
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.
Outcomes
Primary Outcome Measures
Validation of timeframe
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 lesion
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 views
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 size
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 triangulation
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06058650
Brief Title
Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities
Official Title
Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2021 (Actual)
Primary Completion Date
August 26, 2026 (Anticipated)
Study Completion Date
August 26, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part I (technetium Tc-99m sestamibi, MBI)
Arm Type
Experimental
Arm Description
Patients receive technetium Tc-99m sestamibi IV and undergo MBI on study.
Arm Title
Part II (technetium Tc-99m sestamibi, MBI, biopsy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biopsy of Breast
Other Intervention Name(s)
Breast Biopsy
Intervention Description
Undergo biopsy of breast
Intervention Type
Other
Intervention Name(s)
Medical Device Usage and Evaluation
Intervention Description
Utilization of the Stereo Navigator accessory
Intervention Type
Radiation
Intervention Name(s)
Scintimammography
Other Intervention Name(s)
Breast-Specific Gamma Imaging, MBI, Miraluma Scan, Miraluma Test, Molecular Breast Imaging, Nuclear Medicine Breast Imaging, sestamibi breast imaging, Sestamibi Scintimammography
Intervention Description
Undergo MBI
Intervention Type
Other
Intervention Name(s)
Technetium Tc-99m Sestamibi
Other Intervention Name(s)
Cardiolite, Miraluma, Tc 99m Sestamibi, Tc-99m MIBI, Tc99m Sestamibi, Technetium (99mTc) Sestamibi, 99m Tc-methoxy isobutyl isonitrile
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Validation of timeframe
Description
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.
Time Frame
Baseline
Title
Change in image of lesion
Description
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.
Time Frame
Baseline; Up to 6 months
Title
Accuracy of depth estimation by difference in attenuation from opposing views
Description
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.
Time Frame
Baseline; Up to 6 months
Title
Accuracy of depth estimation by difference in apparent lesion size
Description
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.
Time Frame
Baseline; Up to 6 months
Title
Accuracy of depth estimation by triangulation
Description
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.
Time Frame
Baseline; Up to 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katie N. Hunt, M.D.
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Katie N. Hunt, M.D.
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities
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