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NOT YET RECRUITING
NCT07796360
PHASE1

Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

View on ClinicalTrials.gov

Summary

Background: Cerebrospinal fluid (CSF) is the liquid that fills the space around the brain and spinal cord. Researchers do not fully understand how CSF flows and drains around the brain. They want to test a tracer (gadobutrol)-a special dye injected into the CSF-to find out if it is safe to use and can help them get clearer pictures of the CSF during magnetic resonance imaging (MRI) scans of the brain. Objective: To test gadobutrol in the CSF during MRI scans of healthy people. Eligibility: Healthy volunteers aged 18 years and older. They must be screened under NIH protocol 89N0045. Design: Participants will check into the clinic for a 3-day stay. They will have a lumbar puncture: An area on their lower back will be numbed. A thin needle will be inserted into the space around the spinal cord. A sample of CSF will be taken for research. Then a low dose of gadobutrol will be injected into the CSF. Participants will have 4 or 5 MRI scans of the brain-30 minutes, 4 hours, 8 hours (this one is optional), 24 hours, and 48 hours after receiving the gadobutrol. For the scan, they will lie on a table that slides into a cylinder. Special padding will be used to hold their head still. The MRI uses magnetic fields to create images of the inside of the body. Blood and urine samples will also be collected at each scan. Participants will return for an additional MRI 1 week after they leave the clinic. They will have 2 follow-up phone calls 4 and 12 weeks after the start of the study.

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-09-14

Completion Date

2028-03-15

Last Updated

2026-09-03

Healthy Volunteers

No

Interventions

DRUG

Gadobutrol

contrast agent

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States