NCT06873802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

April 11, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2025

Completed
Last Updated

September 9, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

March 11, 2025

Last Update Submit

September 2, 2025

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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.'

    Baseline

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy individuals that can receive a non-contrast enhanced breast MRI

You may qualify if:

  • Age of 18 or older

You may not qualify if:

  • Cardiac pacemaker
  • Implanted cardiac defibrillator
  • Internal pacing wires
  • Cerebral, carotid, or aortic aneurysmal clips
  • Cochlear implants
  • Implanted tissue expanders
  • Claustrophobia
  • Cannot lay prone
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Christine U. Lee, MD, PhD

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 13, 2025

Study Start

April 11, 2025

Primary Completion

July 25, 2025

Study Completion

July 25, 2025

Last Updated

September 9, 2025

Record last verified: 2025-08

Locations

US(1)