Study Evaluating the Safety of Myeliviz Myelin-Targeting PET Agent

Sponsor

Robert Fox (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04333290

Collaborator

Case Western Reserve University (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: [11C]MeDAS	Early Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm: Healthy subjects 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 PET radiotracer Other Names: Myeliviz

Arm

Intervention/Treatment

Experimental: Single Arm: Healthy subjects

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

PET radiotracer

Other Names:

Myeliviz

Outcome Measures

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.