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Can a dye reveal the Brain's hidden fluid pathways?

NCT ID NCT07796360

Knowledge-focused Sponsor: National Institute of Neurological Disorders and Stroke (NINDS) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

Researchers are testing whether a contrast dye called gadobutrol, injected into the fluid around the brain and spinal cord, can safely improve MRI images of how that fluid flows. Healthy volunteers aged 18 and older will receive the dye and undergo several brain scans over a week. The study aims to see if the dye is safe and whether it helps visualize the cerebrospinal fluid spaces more clearly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
gadobutrol, a contrast dye injected into the cerebrospinal fluid
What this could lead to
If it works, this could lead to better imaging of how cerebrospinal fluid moves around the brain, helping researchers understand brain health and disease.
What could go wrong
This is a small early-stage safety study, so the dye may not improve imaging as hoped, and there are risks from the lumbar puncture and contrast agent, such as headache or nausea.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet all the following criteria: * Healthy volunteer. * Age \>= 18 years. To explore age-related effects on tracer dynamics and clearance, 3 cohorts of participants will be recruited: 1) 18-30 years, 2) 30-55 years, and 3) \>55 years; with 2 males and 2 females in each age group. * Able to give written and oral informed consent. * Prior evaluation under NIH protocol 89N0045. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * History of chronic neurological illness, or significant concurrent medical illness. * Contraindication to 3- or 7-tesla MRI * Hypersensitivity reactions to contrast agents. * History of severe allergic reactions. * Pregnancy or breastfeeding. * Renal dysfunction or other serious comorbidities. * Platelet count \<100,000/microliter, INR \> 1.5 or prolonged PT or aPTT at baseline. * Any of the following imaging findings: Mass effect, midline shift, herniation (tonsillar, uncal, subfalcine), or Chiari malformation. * History of seizures or seizure disorder. * Anti-coagulation therapy. * Unwilling to allow coded samples to be processed offsite. * Unwilling to have coded samples and/or data saved or used in other studies.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

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