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RECRUITING
NCT06032026
EARLY_PHASE1

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

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2023-07-20

Completion Date

2028-07-31

Last Updated

2025-11-19

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

11C-HY-2-15 PET

2 hour Positron Emission Tomography (PET) scan using new radiotracer 11C-HY-2-15

DIAGNOSTIC_TEST

brain MRI

brain MRI scan

DIAGNOSTIC_TEST

Amyloid PET scan

PET scan with Florbetaben F18 or 11C-PiB

BEHAVIORAL

Neurological assessments

Neurological assessments, including video interview

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States