- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02236143
Ultrahigh Field Body MR Imaging
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota CMRR
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy male or female volunteer over the age of 18
Exclusion Criteria:
- Exclusion criteria include those associated with the use of MR as the imaging modality. The specific set of exclusion criteria for a given study will depend on the specific study to be performed which will be made clear on initial contact and during consent. In addition, other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures may also arise.
Exclusion criteria will be assessed during a safety screening interview and during final consent. A questionnaire will be provided regarding general health and exclusion/inclusion criteria. The investigator doing the interview will determine if any of the exclusion criteria apply. Subjects will be asked:
- To describe any previous surgeries to help subjects and study staff open a dialogue as to any possible contraindications listed in the yes/no section below.
- If they are claustrophobic and to rate the severity.
- If they wear hearing aids and if they can be removed for the scan.
- If they have a transdermal delivery system, and if yes where is it located and if it can be removed for the study.
- If they wear colored contact lenses and, if yes, can they be removed for the study.
- To provide a list of medications, dosages and time of last dose for medicines taken regularly.
- To identify if they have any pre-existing medical conditions including Hypertension, Hypotension, Diabetes, Cardiovascular Disease and Fever.
- To identify if they ever had an operation.
- To indicate if they have ever been injured by a metallic foreign body which was never removed.
- If they wear braces and/or if they have removable bridgework, false teeth or a permanent retainer.
- If they have any tattoos, non-removable body piercings or hair extensions.
- If they are currently using/wearing an IUD or diaphragm.
- If they have any reason to believe they are pregnant. (If the subjects are unsure about their pregnancy status, test kits will be available to subjects).
- In addition, a set of yes/no questions will be asked in the screening form for the patient to confirm or deny the presence of items that may be hazardous to their safety and/or some interfere with the MRI examination, including:
No Cardiac pacemaker
No Implanted cardiac defibrillator
No Carotid artery vascular clamp
No Intravascular stents, filters, or coils
No Aortic clip
No Internal pacing wires
No Vascular access port and/or catheter
No Swan-Ganz catheter
No Shunt (spinal or intraventricular)
No Aneurysm clip(s)
No Neurostimulator
No Electrodes (on body, head, or brain)
No Heart valve prosthesis
No Any type of prosthesis (eye, penile, etc.)
No Artificial limb or joint replacement
No Bone growth/fusion stimulator
No Bone/joint pin, screw, nail, wire, plate
No Metal rods in bones
No Harrington rods (spine)
No Metal or wire mesh implants
No Wire sutures or surgical staples
No Insulin pump or infusion device
No Any metal fragments (i.e. metal shop)
No Any implant held in place by a magnet
No Cochlear, otologic, or ear implant
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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MRI
Subjects undergoing MRI
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Structure and Function of MRI
Time Frame: Baseline
|
Validate MRI measurement
|
Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Greg Meztger, PhD, University of Minnesota
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 (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1212M24883
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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