Comparing two PET imaging techniques in Huntington Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to compare the effectiveness of two positron emission tomography (PET) imaging techniques, [11C]UCB-J and [18F]SynVest-1, in assessing synaptic density in patients with Huntington Disease (HD). The study will involve healthy controls and HD mutation carriers, focusing on the correlation between synaptic loss and motor impairment. By utilizing advanced imaging methods, the research seeks to establish a reliable biomarker for evaluating synaptic integrity in the human brain affected by HD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Healthy controls (n = 10-20)

   * Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs, clinical laboratory test and urinalysis.
   * No history or evidence of current major neurological, internal or psychiatric disorder, based on the medical assessment as described hereabove and neuropsychological assessment.
   * In subjects \< 60 years of age, an unremarkable structural MRI scan as assessed by expert radiologist. In subjects \>= 60 years of age white matter hyperintensities corresponding to a white matter lesion (WML) Fazekas score \< 2 on the Age-Related White Matter changes scale are acceptable.
2. HD-ISS stage 3 HD mutation carriers (n = 10)

   * HTT CAG repeat expansion 40 - 50
   * stage 3 as determined by the HD-ISS staging criteria
   * UHDRS TFC \>/= 10
3. HD-ISS stage 2 HD mutation carriers (n = 10)

   * HTT CAG repeat expansion 40 - 50
   * stage 2 as determined by the HD-ISS staging criteria
   * PIN score 0.47 - 1.84

Exclusion Criteria:

* Neuropsychiatric diseases; for HD mutation carriers any neuropsychiatric diseases other than HD
* Major internal medical diseases
* White matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities
* History of alcohol abuse or current alcohol abuse (chronic use of more than 15 units per week) or drug use
* Contraindications for MR
* Subject suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures; subject cannot lie still for 30 minutes inside the scanner.
* Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e., weightlifting, running, bicycling) from the time of the pre-study visit until the end of scanning.
* Subject does not understand the study procedures or does not have a guardian who understands the study procedures.
* Subject (or guardian) is unwilling or unable to perform all of the study procedures or is considered unsuitable in any way by the principal investigator.
* Subject is on anticoagulant therapy.
* Subject is pregnant (according to Ulti Med hCG urine test) or breastfeeding.
* Subject is a woman of childbearing potential who does not agree to apply appropriate contraception methods during study participation and continues to do so for at least 6 months after study completion.
* Subject is a man with a pregnant or non-pregnant WOCBP partner, who does not agree to use a condom and continue to do so until 90 days after study completion. In addition, the non-pregnant WOCBP partner should use a highly effective method of contraception.

Where it's running

• UZ Leuven
  Leuven, Belgium Recruiting

Study contacts

• Principal investigator: Koen Van Laere, MD, PhD, DSc — UZ/KU Leuven
• Study coordinator: Koen Van Laere, MD, PhD, DSc
• Email: koen.vanlaere@uzleuven.be
• Phone: +3216343714

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.