Actively Recruiting

Early Phase 1
Age: 40Years - 85Years
All Genders
Healthy Volunteers
ID06303921

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

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

70

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the distribution, metabolism, excretion, and brain uptake of a new radiotracer called 11C-M503. This tracer is designed to measure abnormal alpha-synuclein deposits in the brains of people with Parkinson's disease (PD). The study will compare tracer uptake in individuals with PD, multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and healthy volunteers. This multi-center research project is funded by an NIH U19 grant and involves collaboration among several universities, with the University of Pennsylvania acting as the central review board.

CONDITIONS

Brief 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
  • Male or female participants
  • Willing and able to provide written informed consent
  • Clinical diagnosis of Parkinson's disease, multiple system atrophy, progressive supranuclear palsy, or healthy control as determined by consensus committee
  • Participants with PD, MSA, or PSP are asked but not required to agree to brain donation
Not Eligible

You will not qualify if you...

  • Females who are pregnant or breastfeeding
  • 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
  • Inability to tolerate imaging, arterial line or IV placement, or blood draws
  • Contraindications to MRI, such as incompatible implanted devices
  • Any medical condition considered by a physician to compromise participant safety or study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 4 weeks

Participants undergo PET scans with 11C-M503 and may also have a brain MRI, Amyloid PET scan, and neurological assessments to evaluate brain uptake and other diagnostic measures.

1 to 2 visits depending on imaging and assessments

Long-term Monitoring

Duration - Up to 4 weeks

Participants are monitored for safety and any adverse events following the imaging procedures.

Approximately 1 follow-up visit

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

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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Frequently Asked Questions

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