NCT06303921RecruitingEarly phase 1
Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503
Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Phase I Pilot Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-M503
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 4 Mar 2024
- Start date
- 16 Feb 2024
- Primary completion date
- Feb 2029
- Lead sponsor
- University of Pennsylvania
- Diseases
- Parkinson disease
- NCT number
- NCT06303921
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 70
- From 16 Feb 2024 to the primary completion date, Feb 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Females who are pregnant or breast feeding will be excluded, a urine pregnancy test will be performed in women of child-bearing potential prior to injection of 11C -M503, 11C-PiB or 18F-Florbetaben
Other illness
- Major psychiatric disorder (e.g. schizophrenia or bipolar disorder) - major depressive disorder is allowed
- History of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician or investigator to be a condition that could compromise participant safety or successful participation in the study
Other
- Forms of parkinsonism other than PD, PSP and MSA as defined above
- Contraindications or inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or treating physician
- Contraindication to MRI, such as non-compatible implanted medical device
Who the study is looking for
- Patients in all cohorts will be male or female adults from 40 to 85 years of age.
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures or Participants who are deemed unable to provide informed consent must have a designated study partner present for consent and to accompany them to study visits
- Investigators will ask PD/MSA/PSP participants to agree to brain donation but this choice is not mandatory for participation in this study.
- Diagnosis-specific inclusion criteria: Clinical diagnoses will be determined by consensus committee for diagnostic agreement (PD, MSA, PSP or Healthy Control)
Age in the registry: 40 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Washington University in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.