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Completed

NCT Number: NCT03218111

Glymphatic Kinetics 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.

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical College

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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. -

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

MR Imaging

Other

All subjects will undergo six sessions of MR imaging over a 10-12 hour period

CT-guidance

Other

All subjects will be injected, intrathecally using CT-guidance, with an MRI contrast.

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Biogen

Registry information

Official study title

Evaluation Of Brain Glymphatic Kinetics Following Intrathecal Administration Of Gadolinium In Healthy Adult Volunteers

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2017
Registry last updated
Feb 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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