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OpenTrials
Completed

NCT Number: NCT06873802

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Bone cement marker (BCM) images compared to conventional images

    Time frame: 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.'

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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