Study Evaluating the Safety of Myeliviz Myelin-Targeting PET Agent

Study Overview
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Brief Summary
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This study evaluates the safety of [11C]MeDAS, a PET radiotracer.

Detailed Description
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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.

Official Title
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Phase 1 Study Evaluating the Safety of [11C]MeDAS Myelin-Targeting PET Agent in Humans

Conditions
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Healthy

Intervention / Treatment
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* Drug: [11C]MeDAS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm: Healthy subjects<br>The PET radiotracer Myeliviz ([11C]MeDAS) will be administered to healthy subjects twice and PET scans will be obtained each time. This will allow assessment of the PET image quality, PET scan reproducibility and radiotracer distribution. | Drug: [11C]MeDAS<br>* PET radiotracer<br>* Other names: Myeliviz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Less than or equal to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Less than or equal to 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, myelin, PET, central nervous system, brain, spinal cord, demyelination