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

NCT06058650 | Recruiting DMC FDA Device

• 2 other identifiers: 18-011329NCI-2023-06047
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Part I (technetium Tc-99m sestamibi, MBI)

EXPERIMENTAL

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

Radiation: Scintimammography; Other: Technetium Tc-99m Sestamibi

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

EXPERIMENTAL

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; Other: Medical Device Usage and Evaluation; Radiation: Scintimammography; Other: Technetium Tc-99m Sestamibi

Interventions

Biopsy of Breast PROCEDURE

Undergo biopsy of breast

Also known as: Breast Biopsy

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

Medical Device Usage and Evaluation OTHER

Utilization of the Stereo Navigator accessory

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

Scintimammography RADIATION

Undergo MBI

Also known as: Breast-Specific Gamma Imaging, MBI, Miraluma Scan, Miraluma Test, Molecular Breast Imaging, Nuclear Medicine Breast Imaging, sestamibi breast imaging, Sestamibi Scintimammography

Part I (technetium Tc-99m sestamibi, MBI); Part II (technetium Tc-99m sestamibi, MBI, biopsy)

Technetium Tc-99m Sestamibi OTHER

Given IV

Also known as: Cardiolite, Miraluma, Tc 99m Sestamibi, Tc-99m MIBI, Tc99m Sestamibi, Technetium (99mTc) Sestamibi, 99m Tc-methoxy isobutyl isonitrile

Part I (technetium Tc-99m sestamibi, MBI); Part II (technetium Tc-99m sestamibi, MBI, biopsy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (1)

• Hunt KN, Conners AL, Gray L, Hruska CB, O'Connor MK. Molecular Breast Imaging Biopsy with a Dual-Detector System. Radiol Imaging Cancer. 2024 Jun;6(4):e230186. doi: 10.1148/rycan.230186.

  PMID: 38847615 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Technetium Tc 99m Sestamibi

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Organotechnetium Compounds; Organometallic Compounds

Study Officials

• Katie N. Hunt, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 28, 2023
• Study Start: August 26, 2021
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): August 26, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

US (1)