First-in-Human Evaluation of 18F-SynVesT-1, a Radioligand for PET Imaging of Synaptic Vesicle Glycoprotein 2A.
Mika Naganawa, Songye Li, Nabeel Nabulsi...
https://pubmed.ncbi.nlm.nih.gov/32859701/Actively Recruiting
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-07-30
35
Participants Needed
1
Research Sites
N/A
Total Duration
Positron Emission Tomography PET is a technique that allows visualization of biological molecules in the brain, which is useful for studying neurological and psychiatric disorders. This research focuses on Huntingtons disease HD and evaluates two PET radioligands, 11CUCB-J and 18FSynVest-1, that target synaptic density. Previous studies showed loss of synaptic binding in HD patients, and this trial aims to compare the performance of these two tracers in humans to validate their use as biomarkers for synaptic integrity and disease progression. Participants will undergo PET imaging with both 11CUCB-J and 18FSynVest-1 radioligands to directly compare their binding properties. The study involves two cohorts of HD patients at different disease stages stage 2 and stage 3 and age- and sex-matched healthy controls. The study will analyze data from cohort 1 before proceeding with cohort 2, ensuring a thorough evaluation of tracer performance. This head-to-head comparison will help determine if 18FSynVest-1 can provide similar data quality to 11CUCB-J. During the study, participants will receive PET scans and undergo clinical and neuropsychological assessments to evaluate synaptic density and motor impairment. The main outcome measure is the comparison of volume of distribution Vt between the two tracers in HD patients and controls. Additional analyses include comparing variability and simplified measures of tracer binding. The study will monitor participants for safety and compliance, with participation expected to last through completion of imaging and assessments for both cohorts.
CONDITIONS
Comparison Between [11C]UCB-J and [18F]SynVest-1 PET in HD.
K
Koen Van Laere, MD, PhD, DSc
W
Wim Vandenberghe, MD, PhD
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Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
CHDI Foundation, Inc.
Collaborating Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo PET imaging using [11C]UCB-J and [18F]SynVest-1 to assess synaptic density.
2 imaging visits (in-person)
Duration - Up to 6 months
Participants are observed following imaging to assess outcomes and safety.
1 follow-up visit (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/34663644/Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
CHDI Foundation, Inc.
Collaborating Sponsor