Healthy
Conditions
Keywords
Glymphatic network, healthy, central nervous system
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.
Interventions
OTHERMR Imaging
All subjects will undergo six sessions of MR imaging over a 10-12 hour period
OTHERCT-guidance
All subjects will be injected, intrathecally using CT-guidance, with an MRI contrast.
Sponsors
Biogen
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug distribution over time | 6 time-points over 12 hours | The drug distribution of gadolinium contrast throughout the Central Nervous System over time (12 hours) |
Countries
United States
Outcome results
None listed