NCT03218111

Glymphatic Kinetics In Healthy Adult Volunteers

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

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). 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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	MR Imaging	All subjects will undergo six sessions of MR imaging over a 10-12 hour period
OTHER	CT-guidance	All subjects will be injected, intrathecally using CT-guidance, with an MRI contrast.

Timeline

• Start date: 2017-02-06
• Primary completion: 2018-02-06
• Completion: 2018-02-08
• First posted: 2017-07-14
• Last updated: 2018-02-12

Locations

1 site across 1 country: United States