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

Mayo Clinic20 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Breast Carcinoma

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Bone cement marker (BCM) images compared to conventional images

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.'

Time frame: Baseline

Data from ClinicalTrials.gov

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