Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-HY-2-15
Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Phase I Pilot Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-HY-2-15
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 80 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, 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 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."
- "PET imaging sessions will include an injection of ≤ 20 mCi (approximate range for most studies is anticipated to be 8 - 20 mCi at sites with a standard PET scanner or 3 - 20 at sites with a high sensitivity scanner) of 11C HY-2-15."
- "PET scans will be collected to evaluate image quality and collect preliminary information on brain uptake of 11C HY-2-15 in the disease cohorts and healthy controls."
- 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
The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C HY-2-15. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Multiple System Atrophy (MSA). The investigators will compare uptake in people with MSA with people with Parkinson disease (PD) and progressive supranuclear palsy (PSP) as well as healthy 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) (not a 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
Official eligibility criteria
Inclusion Criteria: * The entire cohort will include men and women clinically diagnosed with MSA, PD, PSP or are healthy controls. A sub-set of these participants who undergo whole body scanning that will be used for analysis of biodistribution and dosimetry calculations. * Patients in all cohorts will be male or female adults from 40 to 80 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 * We 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 HY-2-15, 11C-PiB or 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 * PSP and MSA subjects will be excluded if they have a history of any prior positive ß-amyloid PET scan or positive CSF AD biomarkers. * 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 (1)
PA
- University of Pennsylvania · Philadelphia, PA 19104Erin Schubert · Study contact · 215-662-3041 · erinschu@pennmedicine.upenn.eduIlya Nasrallah, MD, PhD · Principal investigatorMore trials in Philadelphia