Study 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

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.At all participating clinical sites will recruit 20 people with PD, 20 with MSA, 10 with PSP and 20 healthy controls across sites with all participants ranging from 40-85 years old. The investigators will encourage equal participation of males and females.This protocol will include up to 70 participants across all clinical sites (note that at least 10 of these participant scans from Penn may be used to calculate whole body biodistribution (BioD) and dosimetry). The investigators anticipate enrollment of up to 20-25 participants at each clinical site, who will undergo approximately 120 minutes of dynamic brain PET scanning (with or without torso imaging, depending on the clinical site). 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. For participants at Penn that may be part of BioD analysis urine may be collected at the end of the scan session. Participants will also undergo a research brain MRI that may or may not be on a separate day from the PET.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. Biodistribution, metabolism, excretion and pilot brain uptake data will be collected and human dosimetry will be calculated from participants scanned at Penn who have whole body scans. 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. The safety of 11C HY-2-15 will also be evaluated in all participants..

Medienart:

Klinische Studie

Erscheinungsjahr:

2024

Erschienen:

2024

Enthalten in:

ClinicalTrials.gov - (2024) vom: 05. März Zur Gesamtaufnahme - year:2024

Sprache:

Englisch

Links:

Volltext [kostenfrei]

Themen:

610
Phase: Early Phase 1
Recruitment Status: Recruiting
Study Type: Interventional
Tauopathies

Anmerkungen:

Source: Link to the current ClinicalTrials.gov record., First posted: September 11, 2023, Last downloaded: ClinicalTrials.gov processed this data on March 13, 2024, Last updated: March 13, 2024

Study ID:

NCT06032026
853636

Veröffentlichungen zur Studie:

fisyears:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

CTG00001530X