Healthy
Conditions
Keywords
myelin, PET, central nervous system, brain, spinal cord, demyelination, MRI
Brief summary
This study evaluates the safety of \[11C\]MeDAS, a PET radiotracer.
Detailed description
Myelin PET imaging provides a new type of information regarding the integrity of the central nervous system based on molecular imaging of myelin. Preclinical studies have shown \[11C\] MeDAS uptake in the brain and spinal cord to be an indicator of the microstructural integrity of the tissue. \[11C\]MeDAS PET (Positron Emission Tomography) scans will be performed on healthy subjects at 2 timepoints to assess for safety of the radiotracer and to assess its performance in humans. Following measurement of \[11C\]MeDAS pharmacokinetics and biodistribution, an optimal protocol for dosing and imaging will be established.
Interventions
DRUG[11C]MeDAS
PET radiotracer
Sponsors
Case Western Reserve University
Robert Fox
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject reports no known physical diseases of the central nervous system including no history of mental health disorders. * Capable of giving informed consent * Efforts will be made to include approximately equal numbers of women and men. Efforts will be made to include individuals of diverse ethnicities, as reflected in the local clinic population.
Exclusion criteria
* Age \<18 or \>65 * History of malignant hypertension or hypertensive crisis * Known infectious disease requiring treatment during the course of the study * Subject reported history of substance abuse * inability to undergo an MRI or PET scan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution analysis | Less than or equal to 2 hours | Organ-specific radiotracer uptake, as measured using PET scan image data. Radiotracer uptake will be measured in absolute counts and using distribution volume ratios. |
| Pharmacokinetic analysis based on PET scan data | Less than or equal to 2 hours | Determination of time-dependent radiotracer distribution using PET scan image data, with time measurement in minutes, PET data measured in absolute counts, and position in the body determined by organ segmentation. |
| Analysis of time-dependent radiotracer distribution based on arterial blood sampling | Less than or equal to 2 hours | Determination of time-dependent radiotracer distribution as assessed by arterial blood sampling, using scintillation counting for determination of radiotracer activity. Time is measured in minutes and radiotracer quantity is assayed by scintillation counting with units in absolute counts. |
| Radiation dosimetry | Less than or equal to 2 hours | Whole body radiotracer uptake, as measured using PET scan image data. Radiotracer uptake will be measured in absolute counts and using distribution volume ratios. |
| Metabolism analysis | Less than or equal to 2 hours | Analysis of in vivo radiotracer metabolism using liquid chromatography, with quantification of relative peak areas under the curve. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spinal cord imaging characterization | Less than or equal to 2 hours | Analyze patterns of radiotracer distribution in the spinal cord using PET scan image data. This is an intrinsically qualitative analysis and image data will be assessed by visual inspection. Based on findings of this first-in-human study, preliminary quantitative assessment using coregistration with structural imaging, anatomic segmentation and partial volume correction will be performed to calculate distribution volume ratios for areas of interest. |
| Brain imaging characterization | Less than or equal to 2 hours | Analyze patterns of radiotracer distribution in the brain using PET scan image data. This is an intrinsically qualitative analysis and image data will be assessed by visual inspection. Based on findings of this first-in-human study, preliminary quantitative assessment using coregistration with structural imaging, anatomic segmentation and partial volume correction will be performed to calculate distribution volume ratios for areas of interest. |
Countries
United States
Outcome results
None listed