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RecruitingEarly 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 85 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections, Blood draws, MRI scans, PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "A second IV or an arterial line may be placed, preferably in the arm contralateral to the side of injection, for blood metabolite analysis and/or radioactive counts at various times during the scanning session."
  • "These blood draw collections can be omitted at the discretion of the investigator."
  • "Participants will also undergo a research brain MRI that may be on a separate day from the PET."
  • "PET imaging sessions will include an injection of ≤ 15 mCi (approximate range for most studies is anticipated to be 8 - 15 mCi at sites with a standard PET scanner or 3 - 15 at sites with a high sensitivity scanner) of 11C-M503."
  • "PET scans will be collected to evaluate image quality and collect preliminary information on brain uptake of 11C-M503 in the disease cohorts and healthy controls."
  • "Some participants (usually those with positive 11C-M503 PET scan) may also be asked to have an amyloid-beta (Aβ) PET scan to investigate specificity of 11C-M503."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how 11C-M503, a radioactive tracer used in scans, moves through the body, breaks down, leaves the body, and enters the brain. The goal is to measure abnormal buildup of a protein called alpha-synuclein in the brain. It is for adults ages 40–85 with Parkinson’s disease, multiple system atrophy, or progressive supranuclear palsy, and healthy volunteers for comparison.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 40–85 years old.
  • Understand the study and give written consent. If you cannot give consent, a designated study partner must be present for consent and come to study visits.
  • A study committee must confirm Parkinson’s disease, multiple system atrophy, progressive supranuclear palsy, or healthy volunteer status. These diseases affect movement.
  • People with these diseases will be asked to donate their brain after death, but this is not required to join.

Who can't join

  • Be pregnant or breastfeeding. Those who could become pregnant will have a urine pregnancy test before a tracer injection.
  • Have another form of parkinsonism—a condition with movement problems like those in Parkinson’s disease.
  • Have a major mental health disorder, such as schizophrenia or bipolar disorder. Major depression is allowed.
  • Have a history of serious or ongoing alcohol or drug misuse or dependence.
  • Cannot safely have or tolerate scans, a tube placed in an artery or vein, or blood draws.
  • Cannot safely have an MRI scan, such as because of an implanted device that is not MRI-safe.
  • Have another health condition that the study doctor believes could make participation unsafe or prevent you from completing the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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) Exclusion Criteria: * 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 * Forms of parkinsonism other than PD, PSP and MSA as defined above * 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 * 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 * 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

Study sites (3)

CT

MO

PA