Actively Recruiting

Early Phase 1
Age: 40Years - 85Years
All Genders
Healthy Volunteers
NCT06303921

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

Led by University of Pennsylvania · Updated on 2026-04-24

70

Participants Needed

3

Research Sites

258 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 40 to 85 years
  • Willing to provide informed consent or have a designated study partner for consent and visits
  • Clinical diagnosis of Parkinson's disease, multiple system atrophy, progressive supranuclear palsy, or healthy control confirmed by consensus
  • Participants with PD, MSA, or PSP asked to agree to brain donation (optional)
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding females; pregnancy test required for women of child-bearing potential
  • Parkinsonism forms other than PD, PSP, or MSA
  • Major psychiatric disorders such as schizophrenia or bipolar disorder (major depressive disorder allowed)
  • History of significant or ongoing alcohol or substance abuse
  • Contraindications or inability to tolerate imaging, arterial line or IV placement, or blood draws
  • Contraindications to MRI such as non-compatible implanted medical devices
  • Any medical condition or illness deemed by a physician to compromise safety or study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Yale New Haven Hospital

New Haven, Connecticut, United States, 06510

Actively Recruiting

2

Washington University in St. Louis

St Louis, Missouri, United States, 63110

Actively Recruiting

3

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

E

Erin Schubert

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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