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

Pilot Clinical Study to Evaluate Molecular Breast Imaging- Guidance for Sampling of Breast Abnormalities

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasm
• Intervention / Treatment: Radiation: Scintimammography; Other: Technetium Tc-99m Sestamibi; Procedure: Biopsy of Breast; Other: Medical Device Usage and Evaluation

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Katie N. Hunt, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: MBI; Breast-Specific Gamma Imaging; 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.	Radiation: Scintimammography; Undergo MBI; Other Names: MBI; Breast-Specific Gamma Imaging; 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; Procedure: Biopsy of Breast; Undergo biopsy of breast; Other Names: Breast Biopsy; Other: Medical Device Usage and Evaluation; Utilization of the Stereo Navigator accessory

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	Baseline; Up to 6 months
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.	Baseline; Up to 6 months
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.	Baseline; Up to 6 months
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.	Baseline; Up to 6 months

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2021
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): August 26, 2026

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Technetium Tc 99m Sestamibi
• Other Study ID Numbers: 18-011329 (Other Identifier: Mayo Clinic in Rochester); NCI-2023-06047 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes