ZTE MRI Pulse Sequence Use for Visualization of Bone Cement, Breast Biopsy Markers

Recruiting

• Conditions: Breast Carcinoma

• Registration Number: NCT06873802
• Lead Sponsor: Mayo Clinic

Brief Summary

This study is being done to determine if a clinically available MRI sequence called ZTE imaging better visualizes breast biopsy markers made of bone cement compared to the currently used breast biopsy markers made of metal.

Detailed Description

PRIMARY OBJECTIVE:

I. To demonstrate that clinically available ZTE imaging allows for better visualization of bone cement breast biopsy markers when compared to conventional breast biopsy markers and pulse sequences.

OUTLINE: This is an observational study.

Participants undergo standard of care MRI breast imaging with conventional or bone cement breast biopsy markers and complete a questionnaire on study.

Study Timeline

• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Study First Posted: 2025-03-13
• Study Start: 2025-03-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-19
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age of 18 or older

Exclusion Criteria

• Cardiac pacemaker

• Implanted cardiac defibrillator

• Internal pacing wires

• Cerebral, carotid, or aortic aneurysmal clips

• Cochlear implants

• Implanted tissue expanders

• Claustrophobia

• Cannot lay prone

  • Pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone cement marker (BCM) images compared to conventional images	Baseline	Will be assessed using zero echo-time (ZTE) and standard breast biopsy pulse sequences. Two radiologists will interpret images, evaluating the pulse sequences and ZTE images for marker conspicuity. Each sequence will receive a score for conspicuity ranging from 0 to 2. A score of 0 indicates 'not seen, 1 'maybe seen,' and 2 'well seen.'

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States