Study Evaluating the Safety of Myeliviz Myelin-Targeting PET Agent

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: [11C]MeDAS

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Aryn Giffi Scibona, MA; Phone Number: 216-445-8597; Email: giffisa@ccf.org
• Study Contact Backup: Name: Rebecca Algeri, BA; Phone Number: 216-445-3157; Email: algerir@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
      • Contact: Aryn Giffi Scibona, MA; Phone Number: 216-445-8597; Email: giffisa@ccf.org
      • Principal Investigator: Robert Fox, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Robert Fox
• Collaborators: Case Western Reserve University
• Investigators: Principal Investigator: Robert Fox, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: MRI; PET; brain; central nervous system; demyelination; spinal cord; myelin
• Other Study ID Numbers: MeDAS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: data will be available per NIH policies

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No