Study Evaluating the Safety of Myeliviz Myelin-Targeting PET Agent

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04333290
• Other study ID #: MeDAS-001
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: March 2025
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: The Cleveland Clinic
• Contact: Aryn Giffi Scibona, MA
• Phone: 216-445-8597
• Email: giffisa[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [11C]MeDAS
PET radiotracer

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Robert Fox	Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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