Actively Recruiting
Comparison Between [11C]UCB-J and [18F]SynVest-1 PET in HD.
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-07-30
35
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
C
CHDI Foundation, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Positron Emission Tomography (PET) is a functional imaging technique, which enables in vivo visualization of biological molecules expressed in human tissues. Brain PET is most powerful to study a vast range of neurological and psychiatric disorders in vivo, targeting neuronal and glial activity, metabolism, cerebral blood flow, receptor proteins or misfolded proteins. In vivo imaging of synaptic density in the human brain has become feasible through development of \[11C\]UCB-J, a PET radioligand for the synaptic vesicle protein SV2A, which is ubiquitously and homogeneously present in presynaptic terminals throughout the brain. A first study in Huntington's disease (HD) mutation carriers showed loss of striatal \[11C\]UCB-J binding (also when corrected for atrophy), as well as in the neocortex (Delva et al, Neurology 2022). Moreover, regional synaptic loss was highly correlated to motor impairment. In order to be able to use SV2A PET as widespread available biomarker tool to assess synaptic integrity, disease progression and/or response to mHTT lowering drugs, the short half-life of 11C (20 minutes) for \[11C\]UCB-J remains a hurdle. Recently, \[18F\]SynVesT-1, an optimized 18F-labeled analogue of \[11C\]UCB-J with similar kinetics, binding affinity, and test-retest precision properties has been evaluated in humans. However, there is evidence from preclinical studies conducted at University of Antwerp that in the zQ175DN knock-in mouse model of HD, larger variability and lower effect-sizes are seen with \[18F\]SynVest-1 than with \[11C\]UCB-J. In order to ascertain a similar effect size and quantification properties for \[18F\]SynVest-1 and \[11C\]UCB-J PET in human HD patients and to validate simplified measures (such as SUVR with white matter as reference region) and SynVest, this head-to-head fully quantitative study is performed.
CONDITIONS
Official Title
Comparison Between [11C]UCB-J and [18F]SynVest-1 PET in HD.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy controls must be judged in good health by the investigator based on medical history, physical exam, lab tests, and urinalysis.
- Healthy controls must have no history or evidence of major neurological, internal, or psychiatric disorders.
- Healthy controls under 60 years must have an unremarkable brain MRI; those 60 or older may have mild white matter changes (Fazekas score < 2).
- HD mutation carriers must have HTT CAG repeat expansion between 40 and 50.
- HD mutation carriers at stage 3 must have UHDRS Total Functional Capacity score of 10 or higher.
- HD mutation carriers at stage 2 must have PIN score between 0.47 and 1.84.
- HD mutation carriers must be classified as stage 2 or 3 by HD-ISS staging criteria.
- Enrollment aims for 10-20 healthy controls and 10 participants each in HD stages 2 and 3.
You will not qualify if you...
- Presence of neuropsychiatric diseases other than Huntington's disease for HD mutation carriers.
- Major internal medical diseases.
- High white matter lesion load on MRI (Fazekas score 2 or greater) or other relevant MRI abnormalities.
- History or current alcohol abuse exceeding 15 units per week or drug use.
- Contraindications for MRI.
- Claustrophobia or inability to tolerate confinement or lie still during PET-MRI scanning.
- Unwillingness or inability to avoid strenuous physical activity from pre-study until scanning ends.
- Inability to understand study procedures or lack of guardian understanding.
- Inability or unwillingness to complete all study procedures or deemed unsuitable by investigator.
- Current use of anticoagulant therapy.
- Pregnancy or breastfeeding.
- Women of childbearing potential not agreeing to use contraception during study and for 6 months after.
- Men with pregnant or non-pregnant female partners of childbearing potential not agreeing to use condoms during study and for 90 days after, with partner also using effective contraception.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
K
Koen Van Laere, MD, PhD, DSc
CONTACT
W
Wim Vandenberghe, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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