Actively Recruiting
iMagemHTT-009- FIH Evaluation of Novel Mutant Huntingtin PET Radioligand [11C]CHDI-00491009
Led by CHDI Foundation, Inc. · Updated on 2026-03-13
27
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
Sponsors
C
CHDI Foundation, Inc.
Lead Sponsor
U
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a FIH (first-in-human) study to evaluate the clinical utility of the radioligand \[11C\]CHDI-00491009 as a PET tracer that binds specifically to mutant huntingtin (mHTT) aggregates in Huntington's disease (HD). The study is divided into three cohorts defined by the Huntington's Disease Integrated Staging System (HD-ISS): Cohort 1 - initial tracer validation (3 healthy controls (HCs)); Cohort 2 - target validation and test-retest variability (6 HD-ISS Stage 3 participants and 6 age and biological sex-matched HCs); Cohort 3 - target sensitivity (6 HD-ISS Stage 2 participants and 6 age and biological sex-matched HCs). An interim analysis (IA) will be conducted after the completion of each cohort, followed by a final analysis for the study. In addition to imaging, exploratory biomarkers, including somatic instability index, soluble mHTT and total huntingtin (HTT), will be assessed. All participants with HD (PwHD) will have an additional blood sample drawn at the screening visit to assess the somatic instability index and will also be invited to provide an optional cerebrospinal fluid (CSF) sample for measurement of soluble mHTT and total HTT.
CONDITIONS
Official Title
iMagemHTT-009- FIH Evaluation of Novel Mutant Huntingtin PET Radioligand [11C]CHDI-00491009
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 64 years, inclusive
- Body mass index (BMI) between 19 and 35, inclusive
- Capacity to provide written informed consent
- Ability to comply with study procedures including fasting and blood sampling
- Willingness and ability to travel to the imaging center in Leuven, Belgium
- Willingness to use adequate contraceptive measures
- For HD Stage 2 participants: huntingtin gene CAG expansion between 40 and 50, inclusive
- Classified as HD Stage 2 per HD-ISS criteria using the Modified Stage calculator
- PIN score between 0.47 and 1.84 (prognostic index normed for HD)
- For healthy controls: no known family history of HD or tested negative for huntingtin gene CAG expansion if family history present
- Age and biological sex matched to HD participants in Cohorts 2 and 3 (except in Cohort 1)
You will not qualify if you...
- Participation in other therapeutic or imaging studies within 30 days prior
- Prior PET imaging in past 12 months exceeding regulatory radiation limits
- Any disease, condition, or medication that compromises body function or study conduct
- Pregnant or breastfeeding females
- Use of antiplatelet or anticoagulant therapy including acetylsalicylic acid
- Bleeding disorders
- Needle phobia
- Presence of metal objects incompatible with MRI
- Presence of metal objects compatible with MRI located in the head or neck
- Clinically significant abnormal results on safety laboratory tests including positive HBsAg, HepC, HIV-1 or HIV-2
- For HD participants: unstable or inappropriate use of antidepressant, psychoactive, psychotropic or other HD-related medications within 30 days prior
- For healthy controls: family history of HD without genetic testing for huntingtin gene CAG expansion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Universitaire Ziekenhuizen Leuven/ UZ Leuven/ UZL
Leuven, Belgium, 3000
Actively Recruiting
Research Team
W
Wim Vandenberghe, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
3
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