Breast CarcinomaNCT06873802
ZTE MRI Pulse Sequence Use for Visualization of Bone Cement, Breast Biopsy Markers
An observational study of Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2025to 25 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals that can receive a non-contrast enhanced breast MRI
Who may be able to join
- Age of 18 or older
Who cannot join
- Cardiac pacemaker
- Implanted cardiac defibrillator
- Internal pacing wires
- Cerebral, carotid, or aortic aneurysmal clips
- Cochlear implants
- Implanted tissue expanders
Show all 9Show fewer
- Claustrophobia
- Cannot lay prone
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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
- Breast Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Participants undergo standard of care MRI breast imaging with conventional or bone cement breast biopsy markers and complete a questionnaire on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.'
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start11 Apr 2025
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Christine U. Lee, MD, PhD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873802
- Sponsor's protocol ID
- 24-010877
- Other IDs
- NCI-2025-01494, 24-010877, R01EB033008
- Status last verified
- Aug 2025
- First submitted
- 11 Mar 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZTE MRI Pulse Sequence Use for Visualization of Bone Cement, Breast Biopsy Markers
- ClinicalTrials.gov ID
- NCT06873802
- Acronym / sponsor ID
- 24-010877
- Conditions
- Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyParticipants undergo standard of care MRI breast imaging with conventional or bone cement breast biopsy markers and complete a questionnaire on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals that can receive a non-contrast enhanced breast MRI
Key inclusion criteria (1 listed)
- Age of 18 or older
Key exclusion criteria (9 listed)
- Cardiac pacemaker
- Implanted cardiac defibrillator
- Internal pacing wires
- Cerebral, carotid, or aortic aneurysmal clips
- Cochlear implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
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.'
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine U. Lee, MD, PhD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone cement marker (BCM) images compared to conventional images (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.