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

NCT ID: NCT06873802

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-11

Study Completion Date

2025-07-25

Brief Summary

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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

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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.

Conditions

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Breast Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Observational

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

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine U. Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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NCI-2025-01494

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-010877

Identifier Type: OTHER

Identifier Source: secondary_id

R01EB033008

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-010877

Identifier Type: -

Identifier Source: org_study_id

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