Healthy VolunteersPhase 1NCT07796360
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
A Phase 1 study testing Gadobutrol in people with Healthy Volunteers, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Gadobutrol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2026to 15 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Joy Osuebi, Not Listed, joy.osuebi@nih.gov
Maria Gaitan, Not Listed, maria.gaitan@nih.gov
About this study
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.
Read more
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.
Read the detailed description
Study Description:
In this study, we will gather safety data on and establish the technical feasibility of bypassing the blood-brain-barrier (BBB) with intrathecal (IT) gadolinium-based contrast agent (GBCA) tracer injection (0.25 ml gadobutrol at a concentration of 1.0 mmol/ml) to dynamically image the subarachnoid space (SAS) in human healthy volunteers. We will also obtain preliminary data on whether this approach will enable us to reliably visualize physiological meningeal lymphatic drainage pathways within the parasagittal dura (PSD) and connections to cerebrospinal fluid (CSF) compartments using serial contrast-enhanced magnetic resonance imaging (CE-MRI) with minimal confounding signal from tracer blood egress. In exploratory analysis, we will quantify temporal clearance kinetics and investigate distribution patterns of GBCA enhancement in the PSD, CSF spaces, and brain parenchyma in up to 12 healthy volunteers using repeated in vivo CE-MRI over 10 days. Safety/tolerability of the IT GBCA administration will be assessed descriptively over the entire 12-week study period.
Objectives:
Primary objective: To track safety/tolerability of IT GBCA administration in healthy human volunteers.
Secondary objective: To establish technical feasibility of dynamic subarachnoid-space imaging using IT GBCA administration in healthy human volunteers.
Exploratory objectives: To explore patterns of dynamic meningeal lymphatic clearance pathway interconnections in vivo under physiological conditions in human healthy volunteers, and to obtain preliminary data regarding the effect of aging on CSF dynamics and CSF-to-blood tracer clearance.
Endpoints:
Primary endpoint: Occurrence of intervention-emergent adverse events at the participant level assessed descriptively over the 12-week study period.
Secondary outcome measure: MRI detection status (yes/no) of contrast in the cerebral SAS at 24 hours.
Exploratory outcome measures: Changes in contrast-to-noise ratio (CNR) and clearance kinetics of SAS to brain parenchyma over 48h.
- Conditions
- Healthy Volunteers
- Being tested
- Gadobutrol
- Keywords
- gadobutrol, Intrathecal, lymphatics clearance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GadobutrolDrug
contrast agent
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Experimental | 0.25 mmol IT gadobutrol or 0.5 mmol Receives: Drug: Gadobutrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of intervention-emergent adverse events at the participant level assessed descriptively
Systematic recording of adverse events is essential to determine the safety of IT gadobutrol, especially given its off-label use in healthy volunteers. With the limited sample size of this Phase 1 study, safety assessment is appropriately based on a descriptive evaluation rather than formal hypothesis testing. Monitoring known procedure- and contrast-related risks (e.g., post-lumbar puncture headache, nausea, dizziness) as well as any unexpected adverse events over the study and follow-up period provides the critical foundation for ethical justification and regulatory decision-making and is a prerequisite for future feasibility and efficacy-driven studies.
Measured: 12-week study period.
Secondary outcomes (1)
Participant-level MRI detection status (yes/no) of contrast in the cerebral SAS
Technical feasibility is assessed by determining whether IT administered GBCA can be visually detected in the cerebral SAS at 24 hours under exploratory Phase 1 conditions. As this is a pilot safety study with limited prior human data, feasibility is not used as a stopping criterion. Instead, MRI visibility of contrast will inform adaptive dose escalation. If no or insufficient contrast enhancement is observed in 3 to 5 participants at the initial dose level (0.25 ml), the dose may be escalated to 0.5 ml to improve detectability. This predefined adaptation is intended to support appropriate dose selection for subsequent studies while maintaining the focus on safety.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start29 Oct 2026 (estimated)
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Daniel S Reich, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796360
- Sponsor's protocol ID
- 10002744
- Other IDs
- 002744-N
- Status last verified
- 25 Sep 2026
- First submitted
- 29 Aug 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that results in publication
Publications
Eide PK, Ringstad G. Cerebrospinal fluid egress to human parasagittal dura and the impact of sleep deprivation. Brain Res. 2021 Dec 1;1772:147669. doi: 10.1016/j.brainres.2021.147669. Epub 2021 Sep 26.
PubMed 34587499Ringstad G, Eide PK. Safety of Intrathecal Gadolinium-based Contrast Agents and Benefit versus Risk. Radiology. 2021 Apr;299(1):E223-E224. doi: 10.1148/radiol.2021203351. Epub 2021 Feb 16. No abstract available.
PubMed 33591893Patel M, Atyani A, Salameh JP, McInnes M, Chakraborty S. Safety of Intrathecal Administration of Gadolinium-based Contrast Agents: A Systematic Review and Meta-Analysis. Radiology. 2020 Oct;297(1):75-83. doi: 10.1148/radiol.2020191373. Epub 2020 Jul 28.
PubMed 32720867Halvorsen M, Edeklev CS, Fraser-Green J, Lovland G, Vatnehol SAS, Gjertsen O, Nedregaard B, Sletteberg R, Ringstad G, Eide PK. Off-label intrathecal use of gadobutrol: safety study and comparison of administration protocols. Neuroradiology. 2021 Jan;63(1):51-61. doi: 10.1007/s00234-020-02519-4. Epub 2020 Aug 15.
PubMed 32803338Edeklev CS, Halvorsen M, Lovland G, Vatnehol SAS, Gjertsen O, Nedregaard B, Sletteberg R, Ringstad G, Eide PK. Intrathecal Use of Gadobutrol for Glymphatic MR Imaging: Prospective Safety Study of 100 Patients. AJNR Am J Neuroradiol. 2019 Aug;40(8):1257-1264. doi: 10.3174/ajnr.A6136. Epub 2019 Jul 18.
PubMed 31320462Eide PK, Lashkarivand A, Pripp A, Valnes LM, Hovd MH, Ringstad G, Blennow K, Zetterberg H. Plasma neurodegeneration biomarker concentrations associate with glymphatic and meningeal lymphatic measures in neurological disorders. Nat Commun. 2023 Apr 12;14(1):2084. doi: 10.1038/s41467-023-37685-5.
PubMed 37045847Okar SV, Dieckhaus H, Beck ES, Gaitan MI, Norato G, Pham DL, Absinta M, Cortese IC, Fletcher A, Jacobson S, Nair G, Reich DS. Highly Sensitive 3-Tesla Real Inversion Recovery MRI Detects Leptomeningeal Contrast Enhancement in Chronic Active Multiple Sclerosis. Invest Radiol. 2024 Mar 1;59(3):243-251. doi: 10.1097/RLI.0000000000001011.
PubMed 37493285Zhou Y, Cai J, Zhang W, Gong X, Yan S, Zhang K, Luo Z, Sun J, Jiang Q, Lou M. Impairment of the Glymphatic Pathway and Putative Meningeal Lymphatic Vessels in the Aging Human. Ann Neurol. 2020 Mar;87(3):357-369. doi: 10.1002/ana.25670. Epub 2020 Jan 30.
PubMed 31916277Louveau A, Herz J, Alme MN, Salvador AF, Dong MQ, Viar KE, Herod SG, Knopp J, Setliff JC, Lupi AL, Da Mesquita S, Frost EL, Gaultier A, Harris TH, Cao R, Hu S, Lukens JR, Smirnov I, Overall CC, Oliver G, Kipnis J. CNS lymphatic drainage and neuroinflammation are regulated by meningeal lymphatic vasculature. Nat Neurosci. 2018 Oct;21(10):1380-1391. doi: 10.1038/s41593-018-0227-9. Epub 2018 Sep 17.
PubMed 30224810Okar SV, Fagiani F, Absinta M, Reich DS. Imaging of brain barrier inflammation and brain fluid drainage in human neurological diseases. Cell Mol Life Sci. 2024 Jan 12;81(1):31. doi: 10.1007/s00018-023-05073-3.
PubMed 38212566Ringstad G, Eide PK. Cerebrospinal fluid tracer efflux to parasagittal dura in humans. Nat Commun. 2020 Jan 17;11(1):354. doi: 10.1038/s41467-019-14195-x.
PubMed 31953399Eide PK, Lashkarivand A, Hagen-Kersten AA, Gjertsen O, Nedregaard B, Sletteberg R, Lovland G, Vatnehol SAS, Pripp AH, Valnes LM, Ringstad G. Intrathecal Contrast-Enhanced Magnetic Resonance Imaging of Cerebrospinal Fluid Dynamics and Glymphatic Enhancement in Idiopathic Normal Pressure Hydrocephalus. Front Neurol. 2022 Apr 6;13:857328. doi: 10.3389/fneur.2022.857328. eCollection 2022.
PubMed 35463139Eide PK, Pripp AH, Ringstad G, Valnes LM. Impaired glymphatic function in idiopathic intracranial hypertension. Brain Commun. 2021 Mar 21;3(2):fcab043. doi: 10.1093/braincomms/fcab043. eCollection 2021.
PubMed 34235434Eide PK, Mariussen E, Uggerud H, Pripp AH, Lashkarivand A, Hassel B, Christensen H, Hovd MH, Ringstad G. Clinical application of intrathecal gadobutrol for assessment of cerebrospinal fluid tracer clearance to blood. JCI Insight. 2021 May 10;6(9):e147063. doi: 10.1172/jci.insight.147063.
PubMed 33822769Smyth LCD, Xu D, Okar SV, Dykstra T, Rustenhoven J, Papadopoulos Z, Bhasiin K, Kim MW, Drieu A, Mamuladze T, Blackburn S, Gu X, Gaitan MI, Nair G, Storck SE, Du S, White MA, Bayguinov P, Smirnov I, Dikranian K, Reich DS, Kipnis J. Identification of direct connections between the dura and the brain. Nature. 2024 Mar;627(8002):165-173. doi: 10.1038/s41586-023-06993-7. Epub 2024 Feb 7.
PubMed 38326613
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
- ClinicalTrials.gov ID
- NCT07796360
- Acronym / sponsor ID
- 10002744
- Conditions
- Healthy Volunteers
- Keywords
- gadobutrol, Intrathecal, lymphatics clearance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Description:
In this study, we will gather safety data on and establish the technical feasibility of bypassing the blood-brain-barrier (BBB) with intrathecal (IT) gadolinium-based contrast agent (GBCA) tracer injection (0.25 ml gadobutrol at a concentration of 1.0 mmol/ml) to dynamically image the subarachnoid space (SAS) in human healthy volunteers. We will also obtain preliminary data on whether this approach will enable us to reliably visualize physiological meningeal lymphatic drainage pathways within the parasagittal dura (PSD) and connections to cerebrospinal fluid (CSF) compartments using serial contrast-enhanced magnetic resonance imaging (CE-MRI) with minimal confounding signal from tracer blood egress. In exploratory analysis, we will quantify temporal clearance kinetics and investigate distribution patterns of GBCA enhancement in the PSD, CSF spaces, and brain parenchyma in up to 12 healthy volunteers using repeated in vivo CE-MRI over 10 days. Safety/tolerability of the IT GBCA administration will be assessed descriptively over the entire 12-week study period.
Objectives:
Primary objective: To track safety/tolerability of IT GBCA administration in healthy human volunteers.
Secondary objective: To establish technical feasibility of dynamic subarachnoid-space imaging using IT GBCA administration in healthy human volunteers.
Exploratory objectives: To explore patterns of dynamic meningeal lymphatic clearance pathway interconnections in vivo under physiological conditions in human healthy volunteers, and to obtain preliminary data regarding the effect of aging on CSF dynamics and CSF-to-blood tracer clearance.
Endpoints:
Primary endpoint: Occurrence of intervention-emergent adverse events at the participant level assessed descriptively over the 12-week study period.
Secondary outcome measure: MRI detection status (yes/no) of contrast in the cerebral SAS at 24 hours.
Exploratory outcome measures: Changes in contrast-to-noise ratio (CNR) and clearance kinetics of SAS to brain parenchyma over 48h.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | Experimental | Drug: Gadobutrol0.25 mmol IT gadobutrol or 0.5 mmol |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gadobutrolcontrast agent | Drug | Healthy Volunteer |
Primary outcome
Occurrence of intervention-emergent adverse events at the participant level assessed descriptively
Time frame: 12-week study period.
Systematic recording of adverse events is essential to determine the safety of IT gadobutrol, especially given its off-label use in healthy volunteers. With the limited sample size of this Phase 1 study, safety assessment is appropriately based on a descriptive evaluation rather than formal hypothesis testing. Monitoring known procedure- and contrast-related risks (e.g., post-lumbar puncture headache, nausea, dizziness) as well as any unexpected adverse events over the study and follow-up period provides the critical foundation for ethical justification and regulatory decision-making and is a prerequisite for future feasibility and efficacy-driven studies.
1 secondary outcome
Participant-level MRI detection status (yes/no) of contrast in the cerebral SAS
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 34587499Eide PK, Ringstad G. Cerebrospinal fluid egress to human parasagittal dura and the impact of sleep deprivation. Brain Res. 2021 Dec 1;1772:147669. doi: 10.1016/j.brainres.2021.147669. Epub 2021 Sep 26.
- Background: PubMed 33591893Ringstad G, Eide PK. Safety of Intrathecal Gadolinium-based Contrast Agents and Benefit versus Risk. Radiology. 2021 Apr;299(1):E223-E224. doi: 10.1148/radiol.2021203351. Epub 2021 Feb 16. No abstract available.
- Background: PubMed 32720867Patel M, Atyani A, Salameh JP, McInnes M, Chakraborty S. Safety of Intrathecal Administration of Gadolinium-based Contrast Agents: A Systematic Review and Meta-Analysis. Radiology. 2020 Oct;297(1):75-83. doi: 10.1148/radiol.2020191373. Epub 2020 Jul 28.
- Background: PubMed 32803338Halvorsen M, Edeklev CS, Fraser-Green J, Lovland G, Vatnehol SAS, Gjertsen O, Nedregaard B, Sletteberg R, Ringstad G, Eide PK. Off-label intrathecal use of gadobutrol: safety study and comparison of administration protocols. Neuroradiology. 2021 Jan;63(1):51-61. doi: 10.1007/s00234-020-02519-4. Epub 2020 Aug 15.
- Background: PubMed 31320462Edeklev CS, Halvorsen M, Lovland G, Vatnehol SAS, Gjertsen O, Nedregaard B, Sletteberg R, Ringstad G, Eide PK. Intrathecal Use of Gadobutrol for Glymphatic MR Imaging: Prospective Safety Study of 100 Patients. AJNR Am J Neuroradiol. 2019 Aug;40(8):1257-1264. doi: 10.3174/ajnr.A6136. Epub 2019 Jul 18.
- Background: PubMed 37045847Eide PK, Lashkarivand A, Pripp A, Valnes LM, Hovd MH, Ringstad G, Blennow K, Zetterberg H. Plasma neurodegeneration biomarker concentrations associate with glymphatic and meningeal lymphatic measures in neurological disorders. Nat Commun. 2023 Apr 12;14(1):2084. doi: 10.1038/s41467-023-37685-5.
- Background: PubMed 37493285Okar SV, Dieckhaus H, Beck ES, Gaitan MI, Norato G, Pham DL, Absinta M, Cortese IC, Fletcher A, Jacobson S, Nair G, Reich DS. Highly Sensitive 3-Tesla Real Inversion Recovery MRI Detects Leptomeningeal Contrast Enhancement in Chronic Active Multiple Sclerosis. Invest Radiol. 2024 Mar 1;59(3):243-251. doi: 10.1097/RLI.0000000000001011.
- Background: PubMed 31916277Zhou Y, Cai J, Zhang W, Gong X, Yan S, Zhang K, Luo Z, Sun J, Jiang Q, Lou M. Impairment of the Glymphatic Pathway and Putative Meningeal Lymphatic Vessels in the Aging Human. Ann Neurol. 2020 Mar;87(3):357-369. doi: 10.1002/ana.25670. Epub 2020 Jan 30.
- Background: PubMed 30224810Louveau A, Herz J, Alme MN, Salvador AF, Dong MQ, Viar KE, Herod SG, Knopp J, Setliff JC, Lupi AL, Da Mesquita S, Frost EL, Gaultier A, Harris TH, Cao R, Hu S, Lukens JR, Smirnov I, Overall CC, Oliver G, Kipnis J. CNS lymphatic drainage and neuroinflammation are regulated by meningeal lymphatic vasculature. Nat Neurosci. 2018 Oct;21(10):1380-1391. doi: 10.1038/s41593-018-0227-9. Epub 2018 Sep 17.
- Background: PubMed 38212566Okar SV, Fagiani F, Absinta M, Reich DS. Imaging of brain barrier inflammation and brain fluid drainage in human neurological diseases. Cell Mol Life Sci. 2024 Jan 12;81(1):31. doi: 10.1007/s00018-023-05073-3.
- Background: PubMed 31953399Ringstad G, Eide PK. Cerebrospinal fluid tracer efflux to parasagittal dura in humans. Nat Commun. 2020 Jan 17;11(1):354. doi: 10.1038/s41467-019-14195-x.
- Background: PubMed 35463139Eide PK, Lashkarivand A, Hagen-Kersten AA, Gjertsen O, Nedregaard B, Sletteberg R, Lovland G, Vatnehol SAS, Pripp AH, Valnes LM, Ringstad G. Intrathecal Contrast-Enhanced Magnetic Resonance Imaging of Cerebrospinal Fluid Dynamics and Glymphatic Enhancement in Idiopathic Normal Pressure Hydrocephalus. Front Neurol. 2022 Apr 6;13:857328. doi: 10.3389/fneur.2022.857328. eCollection 2022.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that results in publication
Related trials for Healthy Volunteers
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel S Reich, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gadobutrol in people with Healthy Volunteers, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria I Gaitan, M.D. ((301) 496-1801, maria.gaitan@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of intervention-emergent adverse events at the participant level assessed descriptively (time frame: 12-week study period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07796360, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.