- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06452459
Glymphatic MRI Study
June 5, 2024 updated by: Juan Piantino, Oregon Health and Science University
Evaluation of Glymphatic Function With MRI
This study aims at identifying neuroimaging markers of glymphatic function in humans.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
10
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Healthy adults
Description
Inclusion Criteria:
- Ability to undergo MRI without anesthesia
- Calculated GFR greater or equal to 60 mL/min/1.73 m2
Exclusion Criteria:
- Inability to obtain consent
- Subject is incarcerated, pregnant, or lactating or suspects they may be pregnant
- Known allergic or hypersensitivity reactions to gadolinium
- Three or more drug allergies from separate drug classes
- Recent or expected beed for imaging with iodinated contrast
- Contraindications to MRI: claustrophobia, weight greater than maximum MRI scanner capacity, presence of metallic foreign body, or implanted devices not documented as MRI safe
- History of neurosurgical procedure or cervical surgery
- Current use of anticoagulation medications
- Contraindication to lumbar puncture (creatinine or INR elevated above laboratory standard cutoffs)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Contrast enhancement
Time Frame: 2 weeks
|
Measurement of contrast intensity in brain parenchyma
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2028
Study Registration Dates
First Submitted
June 5, 2024
First Submitted That Met QC Criteria
June 5, 2024
First Posted (Actual)
June 11, 2024
Study Record Updates
Last Update Posted (Actual)
June 11, 2024
Last Update Submitted That Met QC Criteria
June 5, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IT Gadolinium Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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.