Study Evaluating the Safety of Myeliviz Myelin-Targeting PET Agent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-24

Study Completion Date

2024-07-25

Brief Summary

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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

[11C]MeDAS

Intervention Type DRUG

PET radiotracer

Interventions

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[11C]MeDAS

PET radiotracer

Intervention Type DRUG

Other Intervention Names

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Myeliviz

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes