Glymphatic Kinetics In Healthy Adult Volunteers

NCT ID: NCT03218111

Last Updated: 2018-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-06
• Study Completion Date: 2018-02-08

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy Normal Subjects

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

Group Type: OTHER

MR Imaging

Intervention Type: OTHER

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

CT-guidance

Intervention Type: OTHER

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

Interventions

MR Imaging

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

Intervention Type: OTHER

CT-guidance

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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

2. Age 20-80

3. Willing to undergo multiple imaging sessions

4. 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.

5. If female of childbearing age: negative pregnancy test

6. Normal Basic metabolic Panel and CBC (Platelet count > 150,000; Hb >8)

7. Willing to undergo LP procedure. -

Exclusion Criteria

1. Kyphosis

2. Claustrophobia

3. Chronic cough

4. Active infection with fever (>101.5), to limit risk of meningitis. Infections could include pneumonia, pharyngitis, skin infection, UTI, etc.

5. History of CNS tumor or anomaly

6. History of radiation therapy to the CNS

7. History of hydrocephalus

8. Abnormality on MRI that could impede CSF flow (i.e., extruded disk)

9. Laboratory finding of prolonged coagulation times

10. Pregnant/nursing

11. Prior spine or brain surgery or trauma

12. Inability to lay still and supine

13. Recent lumbar puncture within 1 month of planned LP.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J. Levi Chazen, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical College

New York, New York, United States

Countries

United States

Other Identifiers

1609017536

Identifier Type: -

Identifier Source: org_study_id