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Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503
NCT06303921 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Neurological assessments
- DRUG 11C-M503 PET
- DIAGNOSTIC_TEST Brain MRI
- DIAGNOSTIC_TEST Amyloid PET
Study Locations (3)
Connecticut
- Yale New Haven Hospital — New Haven
Missouri
- Washington University in St. Louis — St Louis
Pennsylvania
- University of Pennsylvania — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-02-16 |
| Est. Completion | 2029-02 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06303921
The ClinicalTrials.gov registry entry for NCT06303921 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Tauopathies appearing as the primary indexed condition, and to 4 interventions — of which Neurological assessments is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06303921 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Connecticut, Missouri, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06303921 about?
NCT06303921 is a clinical study titled "Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503". 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 participan...
What is the current status of trial NCT06303921?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 70 participants. The study started on 2024-02-16. Estimated completion is 2029-02.
What conditions does trial NCT06303921 study?
This clinical trial studies the following conditions: Tauopathies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06303921?
The interventions under investigation include: Neurological assessments (BEHAVIORAL), 11C-M503 PET (DRUG), Brain MRI (DIAGNOSTIC_TEST), Amyloid PET (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06303921?
This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06303921 being conducted?
This trial has 3 study locations across Connecticut, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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