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Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT06058650
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
60
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biopsy of Breast
  • Other: Medical Device Usage and Evaluation
  • Radiation: Scintimammography
  • Other: Technetium Tc-99m Sestamibi
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities
Actual Study Start Date :
Aug 26, 2021
Anticipated Primary Completion Date :
Aug 26, 2026
Anticipated Study Completion Date :
Aug 26, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part I (technetium Tc-99m sestamibi, MBI)

Patients receive technetium Tc-99m sestamibi IV and undergo MBI on study.

Radiation: Scintimammography
Undergo MBI
Other Names:
  • Breast-Specific Gamma Imaging
  • MBI
  • Miraluma Scan
  • Miraluma Test
  • Molecular Breast Imaging
  • Nuclear Medicine Breast Imaging
  • sestamibi breast imaging
  • Sestamibi Scintimammography

    • Other: Technetium Tc-99m Sestamibi
    Given IV
    Other Names:
  • Cardiolite
  • Miraluma
  • Tc 99m Sestamibi
  • Tc-99m MIBI
  • Tc99m Sestamibi
  • Technetium (99mTc) Sestamibi
  • 99m Tc-methoxy isobutyl isonitrile

    		•
    Experimental: Part II (technetium Tc-99m sestamibi, MBI, biopsy)

    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.

    Procedure: Biopsy of Breast
    Undergo biopsy of breast
    Other Names:
  • Breast Biopsy

    • Other: Medical Device Usage and Evaluation
    Utilization of the Stereo Navigator accessory

    Radiation: Scintimammography
    Undergo MBI
    Other Names:
  • Breast-Specific Gamma Imaging
  • MBI
  • Miraluma Scan
  • Miraluma Test
  • Molecular Breast Imaging
  • Nuclear Medicine Breast Imaging
  • sestamibi breast imaging
  • Sestamibi Scintimammography

    • Other: Technetium Tc-99m Sestamibi
    Given IV
    Other Names:
  • Cardiolite
  • Miraluma
  • Tc 99m Sestamibi
  • Tc-99m MIBI
  • Tc99m Sestamibi
  • Technetium (99mTc) Sestamibi
  • 99m Tc-methoxy isobutyl isonitrile

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Validation of timeframe [Baseline]

      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.

    2. Change in image of lesion [Baseline; 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.

    3. Accuracy of depth estimation by difference in attenuation from opposing views [Baseline; 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.

    4. Accuracy of depth estimation by difference in apparent lesion size [Baseline; 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.

    5. Accuracy of depth estimation by triangulation [Baseline; 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Katie N. Hunt, M.D., Mayo Clinic in Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT06058650
    Other Study ID Numbers:
    • 18-011329
    • NCI-2023-06047
    • 18-011329
    First Posted:
    Sep 28, 2023
    Last Update Posted:
    Sep 28, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Breast Neoplasms
    Technetium Tc 99m Sestamibi

    Study Results

    No Results Posted as of Sep 28, 2023