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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR Imaging | Other | All subjects will undergo six sessions of MR imaging over a 10-12 hour period |
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| Measure | Description | Time Frame |
|---|---|---|
| Drug distribution over time | The drug distribution of gadolinium contrast throughout the Central Nervous System over time (12 hours) | 6 time-points over 12 hours |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| J. Levi Chazen, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10021 | United States |
No Current Plan
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| CT-guidance | Other | All subjects will be injected, intrathecally using CT-guidance, with an MRI contrast. |
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