HealthyNCT03218111
Glymphatic Kinetics In Healthy Adult Volunteers
A study testing MR Imaging and CT-guidance in people with Healthy, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study is being done in order to see how gadolinium-based MRI contrast (Magnevist) travels through the central nervous system (CNS) when injected through the spinal column, and to compare differences between two age groups (age 20-50, and 51-80). Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MR Imaging and CT-guidance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2017to 8 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Deemed healthy and able to undergo MR imaging by the Site Investigator, based on screening assessments:
- medical history, physical examination, vital signs, and clinical laboratory values
- Age 20-80
- Willing to undergo multiple imaging sessions
- Normal screening MRI to exclude subjects with a mass (e.g., disk herniation), congenital malformation (e.g., Chiari malformation), or an abnormal curvature of the spine that could alter CSF flow.
- If female of childbearing age: negative pregnancy test
- Normal Basic metabolic Panel and CBC (Platelet count > 150,000; Hb >8)
- Willing to undergo LP procedure. -
Who cannot join
- Kyphosis
- Claustrophobia
- Chronic cough
- Active infection with fever (>101.5), to limit risk of meningitis. Infections could include pneumonia, pharyngitis, skin infection, UTI, etc.
- History of CNS tumor or anomaly
- History of radiation therapy to the CNS
Show all 13Show fewer
- History of hydrocephalus
- Abnormality on MRI that could impede CSF flow (i.e., extruded disk)
- Laboratory finding of prolonged coagulation times
- Pregnant/nursing
- Prior spine or brain surgery or trauma
- Inability to lay still and supine
- Recent lumbar puncture within 1 month of planned LP.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: Evaluation Of Brain Glymphatic Kinetics Following Intrathecal Administration Of Gadolinium In Healthy Adult Volunteers
This study is being done in order to see how gadolinium-based MRI contrast (Magnevist) travels through the central nervous system (CNS) when injected through the spinal column, and to compare differences between two age groups (age 20-50, and 51-80). This will allow investigators to evaluate how much contrast has crossed into the tissue surrounding the brain. Such information will help investigators determine whether this kind of contrast can be used to model how other drugs might travel through the CNS and evaluate its use as an illustrative imaging marker that mirrors the glymphatic system.
Read the detailed description
This is a prospective, longitudinal study of MR imaging of intrathecally delivered gadolinium contrast (Magnevist, Gd-DTPA) in healthy adult male and female subjects. Subjects will be divided into two groups (20-50 years old and 51-80 years old) both of which will receive intrathecal injection of the drug Magnevist (Gd-DTPA), followed by serial MR imaging over the course of 10-12 hours. The purpose of the study is determine the transport kinetics of Central Nervous System (CNS) exposure to gadolinium contrast injected into the lumbar intrathecal space (lower back) and evaluate changes with age. This will allow investigators to evaluate the brain parenchymal penetration of gadolinium as an illustrative imaging marker that mirrors the glymphatic system. Investigators hypothesize the exposure and penetration patterns of the neuraxis to neurotherapeutic drugs can be modeled using gadolinium intrathecal contrast administered in the lumbar intrathecal space.
- Conditions
- Healthy
- Being tested
- MR Imaging, CT-guidance
- Keywords
- Glymphatic network, healthy, central nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR ImagingOther
All subjects will undergo six sessions of MR imaging over a 10-12 hour period
CT-guidanceOther
All subjects will be injected, intrathecally using CT-guidance, with an MRI contrast.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Normal Subjects | Other | Healthy normal subjects 20-80 years old. All subjects will undergo the same procedures: intrathecal injection, using CT-guidance, with an MRI contrast. After injection subjects will undergo six sessions of MR imaging over a 10-12 hour period Receives: Other: MR Imaging; Other: CT-guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug distribution over time
The drug distribution of gadolinium contrast throughout the Central Nervous System over time (12 hours)
Measured: 6 time-points over 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start6 Feb 2017
- Primary completion6 Feb 2018
- Study completion8 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- J. Levi Chazen, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218111
- Sponsor's protocol ID
- 1609017536
- Status last verified
- Feb 2018
- First submitted
- 7 Jul 2017
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Current Plan
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Brain Glymphatic Kinetics Following Intrathecal Administration Of Gadolinium In Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03218111
- Acronym / sponsor ID
- 1609017536
- Conditions
- Healthy
- Keywords
- Glymphatic network, healthy, central nervous system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 14 Jul 2017 (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.
This study is being done in order to see how gadolinium-based MRI contrast (Magnevist) travels through the central nervous system (CNS) when injected through the spinal column, and to compare differences between two age groups (age 20-50, and 51-80). This will allow investigators to evaluate how much contrast has crossed into the tissue surrounding the brain. Such information will help investigators determine whether this kind of contrast can be used to model how other drugs might travel through the CNS and evaluate its use as an illustrative imaging marker that mirrors the glymphatic system.
Detailed description
This is a prospective, longitudinal study of MR imaging of intrathecally delivered gadolinium contrast (Magnevist, Gd-DTPA) in healthy adult male and female subjects. Subjects will be divided into two groups (20-50 years old and 51-80 years old) both of which will receive intrathecal injection of the drug Magnevist (Gd-DTPA), followed by serial MR imaging over the course of 10-12 hours. The purpose of the study is determine the transport kinetics of Central Nervous System (CNS) exposure to gadolinium contrast injected into the lumbar intrathecal space (lower back) and evaluate changes with age. This will allow investigators to evaluate the brain parenchymal penetration of gadolinium as an illustrative imaging marker that mirrors the glymphatic system. Investigators hypothesize the exposure and penetration patterns of the neuraxis to neurotherapeutic drugs can be modeled using gadolinium intrathecal contrast administered in the lumbar intrathecal space.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Normal Subjects | Other | Other: MR Imaging, Other: CT-guidanceHealthy normal subjects 20-80 years old. All subjects will undergo the same procedures: intrathecal injection, using CT-guidance, with an MRI contrast. After injection subjects will undergo six sessions of MR imaging over a 10-12 hour period |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Deemed healthy and able to undergo MR imaging by the Site Investigator, based on screening assessments:
- medical history, physical examination, vital signs, and clinical laboratory values
- Age 20-80
- Willing to undergo multiple imaging sessions
- Normal screening MRI to exclude subjects with a mass (e.g., disk herniation), congenital malformation (e.g., Chiari malformation), or an abnormal curvature of the spine that could alter CSF flow.
Key exclusion criteria (13 listed)
- Kyphosis
- Claustrophobia
- Chronic cough
- Active infection with fever (>101.5), to limit risk of meningitis. Infections could include pneumonia, pharyngitis, skin infection, UTI, etc.
- History of CNS tumor or anomaly
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 |
|---|---|---|
| MR ImagingAll subjects will undergo six sessions of MR imaging over a 10-12 hour period | Other | Healthy Normal Subjects |
| CT-guidanceAll subjects will be injected, intrathecally using CT-guidance, with an MRI contrast. | Other | Healthy Normal Subjects |
Primary outcome
Drug distribution over time
Time frame: 6 time-points over 12 hours
The drug distribution of gadolinium contrast throughout the Central Nervous System over time (12 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Individual participant dataSharing planned: No. No Current Plan
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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. This study is not recruiting at the moment.
J. Levi Chazen, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR Imaging and CT-guidance in people with Healthy, run by Weill Medical College of Cornell University 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 8 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: finished, as of the sponsor's last update on 12 Feb 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug distribution over time (time frame: 6 time-points over 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2018.