- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04769960
Study of the Safety of MRI Scans in People Who Have Breast Tissue Expanders After Mastectomy
A Pilot Safety Study for Performing MRI in Patients Who Have Breast Tissue Expanders
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New Jersey
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen (Consent Only )
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack (Consent only)
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Patients with breast tissue expanders that require an MRI for clinical purposes are eligible for this study. Patients must provide an implant card or surgical report indicated the exact make and model of their implanted tissue expander. Breast tissue expanders marked as "MRI unsafe" will be allowed with exceptions as described in the Participant exclusion criteria. While all types of MRI will be included in this study, including breast MRI, we anticipate that most of the MRI examinations ordered will evaluate the brain or spine for detecting or following metastasis.
Inclusion Criteria:
- Patient ≥ 18 years old on day of signing informed consent
- Has a breast tissue expander implanted > 28 days ago
- Patients must provide an implant card or surgical report indicated the exact make and model of their implanted tissue expander
Exclusion Criteria:
- Patients with AeroForm Tissue Expanders (manufactured by AirXpanders)
- Anyone who would normally be excluded from undergoing an MRI examination as per the Memorial Hospital for Cancer and Allied Diseases screening policy in the MRI Safety Policy (https://one.mskcc.org/sites/pub/ehs/Policies/ECSE-2009.pdf), aside from having a breast tissue expander
- Patients who are reportedly pregnant, who have a positive urine or serum pregnancy test at the time of imaging, or for which pregnancy cannot be ruled out.
- Patients who are unable to tolerate, comply or complete the MRI exam due to claustrophobia, anxiety, known psychiatric or substance abuse disorder, age, frailty, or medical instability.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Participants with breast tissue expanders
Participants with breast tissue expanders that require an MRI for clinical purposes are eligible for this study.
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MRI scans will be performed on a 1.5T MRI scanner.
Department of Radiology MRI SafetyGuidelines will be followed except regarding breast tissue expanders.
Conventional MRIstudies will be performed using the standard of care clinical sequences.
Participants will fill out questionnaires before, immediately after, and approximately 3 months following the MRI examination +/- 1 month to evaluate for any pain or perceived changes with the breast tissue expander.
The first questionnaire will obtain background participants information as well as establish a baseline pain level, the second questionnaire will evaluate any changes in pain after undergoing the MRI examination, and the last questionnaire will evaluate long term changes in pain.
The patient reported outcome questionnaire will be optional at 3 months post-MRI +/-1 month.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of MRI scans for patients with breast tissue expanders
Time Frame: 2 years
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Our first aim is to assess the safety of imaging patients with breast tissue expanders in the MRI.
Among the 50 MRI scans, if we can successfully complete at least 50, meaning that there are no issues of burning, heating, or pain in the region of the breast tissue expander that prevents the completion of the MRI, then we will declare the imaging safe and worthy of further investigation.
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2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Alicia Meng, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-055
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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