Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06058650

Conditions

Breast Neoplasm

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy of Breast

Medical Device Usage and Evaluation

Scintimammography

Technetium Tc-99m Sestamibi

Study Details

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

Study ID

NCT06058650

Start date

Aug 26, 2021

Status verified date

Sep, 2025

Completion date

Aug 26, 2026

Anticipated

Primary completion date

Aug 26, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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

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.

Interventions

Biopsy of Breast

Undergo biopsy of breast

Medical Device Usage and Evaluation

Utilization of the Stereo Navigator accessory

Scintimammography

Undergo MBI

Technetium Tc-99m Sestamibi

Given IV

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Katie N. Hunt, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-09-30.