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

Overview

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.

Interventions

• Procedure Biopsy of Breast
  Undergo biopsy of breast
• Other Medical Device Usage and Evaluation
  Utilization of the Stereo Navigator accessory
• Radiation Scintimammography
  Undergo MBI
• Other Technetium Tc-99m Sestamibi
  Given IV

Primary outcome measures

• Validation of timeframe [Time frame: Baseline]
• Change in image of lesion [Time frame: Baseline; Up to 6 months]
• Accuracy of depth estimation by difference in attenuation from opposing views [Time frame: Baseline; Up to 6 months]
• Accuracy of depth estimation by difference in apparent lesion size [Time frame: Baseline; Up to 6 months]
• Accuracy of depth estimation by triangulation [Time frame: Baseline; Up to 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Mayo Clinic in Rochester — Rochester

Publications

• 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

Identifiers

NCT: NCT06058650 · 18-011329 · NCI-2023-06047 · 18-011329

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗