This study evaluates the safety of \[11C\]MeDAS, a PET radiotracer.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
PET radiotracer
Cleveland Clinic
Cleveland, Ohio, United States
Radiation dosimetry
Whole body radiotracer uptake, as measured using PET scan image data. Radiotracer uptake will be measured in absolute counts and using distribution volume ratios.
Time frame: Less than or equal to 2 hours
Biodistribution analysis
Organ-specific radiotracer uptake, as measured using PET scan image data. Radiotracer uptake will be measured in absolute counts and using distribution volume ratios.
Time frame: Less than or equal to 2 hours
Metabolism analysis
Analysis of in vivo radiotracer metabolism using liquid chromatography, with quantification of relative peak areas under the curve.
Time frame: Less than or equal to 2 hours
Pharmacokinetic analysis based on PET scan data
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.
Time frame: Less than or equal to 2 hours
Analysis of time-dependent radiotracer distribution based on arterial blood sampling
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.
Time frame: Less than or equal to 2 hours
Brain imaging characterization
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.
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Time frame: Less than or equal to 2 hours
Spinal cord imaging characterization
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.
Time frame: Less than or equal to 2 hours