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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06873802
Enrollment
20
Registered
2025-03-13
Start date
2025-04-11
Completion date
2025-07-25
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma

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.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Sponsors

National Institute for Biomedical Imaging and Bioengineering (NIBIB)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Bone cement marker (BCM) images compared to conventional imagesBaselineWill 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.'

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026