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[11C]MeDAS PET Scan Safety for Healthy Subjects

Phase < 1
Waitlist Available
Led By Robert Fox, MD
Research Sponsored by Robert Fox
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capable of giving informed consent
Subject reports no known physical diseases of the central nervous system including no history of mental health disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up less than or equal to 2 hours
Awards & highlights

Study Summary

This trial looks at the safety of a new PET scan called [11C]MeDAS.

Who is the study for?
This trial is for healthy adults aged 18 to 65 with no central nervous system diseases or mental health disorders. It seeks a diverse group of participants, including equal numbers of women and men from various ethnic backgrounds. Those with infectious diseases, substance abuse history, extreme hypertension, or who can't have MRI/PET scans cannot join.Check my eligibility
What is being tested?
[11C]MeDAS is being tested in this study. It's a PET radiotracer designed to target myelin in the brain to help visualize nerve insulation. The safety of this agent will be evaluated when administered to healthy volunteers.See study design
What are the potential side effects?
As [11C]MeDAS is under evaluation for its safety profile, potential side effects are not fully known but may include reactions typical of PET radiotracers such as discomfort at injection site or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I understand the study and can agree to participate.
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I have no known brain diseases or mental health disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~less than or equal to 2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and less than or equal to 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analysis of time-dependent radiotracer distribution based on arterial blood sampling
Biodistribution analysis
Metabolism analysis
+2 more
Secondary outcome measures
Brain imaging characterization
Spinal cord imaging characterization

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm: Healthy subjectsExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Robert FoxLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
260,074 Total Patients Enrolled
Robert Fox, MDPrincipal InvestigatorThe Cleveland Clinic

Media Library

[11C]MeDAS 2023 Treatment Timeline for Medical Study. Trial Name: NCT04333290 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are persons above a certain age eligible for participation in the project?

"As dictated by the inclusion criteria, only individuals between 18 to 65 years of age are eligible for this trial. Separately, there are 50 clinical trials available for minors and 371 studies offered to seniors."

Answered by AI

Is the recruitment process for this trial currently open to new participants?

"As evidenced on clinicaltrials.gov, this trial has concluded its recruitment process and is no longer accepting participants; the initial post was made January 1st 2023 while it was last updated February 3rd 2022. Fortunately, 839 other studies are actively looking for willing study-subjects at present time."

Answered by AI

Do I meet the qualifications to join this research project?

"This medical trial seeks 20 participants aged 18 to 65 with no known physical diseases of the central nervous system or history of mental health disorders. In order to ensure representation from a variety of backgrounds, efforts will be made to have an equal number of male and female subjects as well as diverse ethnicities reflective in the local population."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Cleveland Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study Evaluating the Safety of Myeliviz Myelin-Targeting PET Agent
Robert Fox 2025. "Study Evaluating the Safety of Myeliviz Myelin-Targeting PET Agent". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04333290.
All > Spinal Cord
~13 spots leftby Dec 2025
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