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RECRUITING
NCT06303921
EARLY_PHASE1

Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

Summary

The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C-M503. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Parkinson's disease (PD). Investigators will compare uptake in participants with PD versus participants with multiple system atrophy (MSA) and progressive supranuclear palsy (PSP), as well as non-Parkinsonism volunteers. This multicenter project funded by an NIH U19 grant, is centered at U Pennsylvania (Penn, Grant PI: Robert Mach) in collaboration with U Pittsburgh (Pitt) (non-clinical site) Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites.

Official title: Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Phase I Pilot Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-M503

Key Details

Gender

All

Age Range

40 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2024-02-16

Completion Date

2029-02

Last Updated

2025-04-22

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

11C-M503 PET

2 hour Positron Emission Tomography (PET) scan using new radiotracer 11C-M503

DIAGNOSTIC_TEST

Brain MRI

MRI scan of brain.

DIAGNOSTIC_TEST

Amyloid PET

PET scan with Florbetaben F18 or 11C-PiB

BEHAVIORAL

Neurological assessments

Neurological assessments, including a video interview.

Locations (3)

Yale New Haven Hospital

New Haven, Connecticut, United States

Washington University in St. Louis

St Louis, Missouri, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States