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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-01494 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24-010877 | Other Identifier | Mayo Clinic Institutional Review Board | |
| R01EB033008 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Participants undergo standard of care MRI breast imaging with conventional or bone cement breast biopsy markers and complete a questionnaire on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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
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Healthy individuals that can receive a non-contrast enhanced breast MRI
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| Name | Affiliation | Role |
|---|---|---|
| Christine U. Lee, MD, PhD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 3, 2025 | Sep 2, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |