Actively Recruiting

Early Phase 1
Age: 40Years - 80Years
All Genders
Healthy Volunteers
ID06032026

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

Led by University of Pennsylvania · Updated on 2025-11-19

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the biodistribution, metabolism, excretion, and brain uptake of a new radiotracer called 11C HY-2-15. This radiotracer is designed to measure abnormal alpha-synuclein deposits in the brains of people with Multiple System Atrophy (MSA). The study also compares these results with people having Parkinson disease (PD), progressive supranuclear palsy (PSP), and healthy volunteers. This multicenter project is funded by an NIH U19 grant and is coordinated by the University of Pennsylvania alongside several other institutions.

CONDITIONS

Brief Title

Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-HY-2-15

Who Can Participate

Age: 40Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women clinically diagnosed with Multiple System Atrophy, Parkinson disease, progressive supranuclear palsy, or healthy controls
  • Adults aged 40 to 80 years
  • Willing and able to provide written informed consent
  • Diagnosis confirmed by consensus committee for PD, MSA, PSP, or healthy control
  • Participants may agree to brain donation but it is not required for participation
Not Eligible

You will not qualify if you...

  • Females who are pregnant or breastfeeding
  • Forms of parkinsonism other than PD, PSP, and MSA
  • Major psychiatric disorders such as schizophrenia or bipolar disorder
  • History of significant or ongoing alcohol or substance abuse
  • Inability to tolerate imaging, arterial line, IV placement, or blood draws
  • Contraindications to MRI, such as non-compatible implanted medical devices
  • PSP and MSA subjects with prior positive beta-amyloid PET scan or positive CSF Alzheimer's disease biomarkers
  • Any medical condition that could compromise safety or participation as assessed by a physician or investigator

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 - 1 day

Participants undergo diagnostic imaging including a 2-hour PET scan using the radiotracer 11C-HY-2-15, and may also have a brain MRI and Amyloid PET scan to assess brain uptake and biodistribution of the tracer.

1 imaging session (in-person)

Monitoring

Duration - Up to 4 weeks

Participants are monitored for safety and tolerability following the imaging procedures, including neurological assessments and observation for any adverse events.

Follow-up visits as needed within 4 weeks

Trial Site Locations

Total: 1 location

1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

E

Erin o Schubert

M

Mary Hansbury

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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