Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05224115
Other study ID # s64086
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 17, 2020
Est. completion date October 13, 2020

Study information

Verified date May 2022
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A better understanding of the HD pathogenesis mechanisms may lead to a better understanding of disease pathology, progression and development of targeted therapies. [11C]CHDI-00485180-R and [11C]CHDI-00485626 are two novel mutant huntingtin aggregate binding PET radioligands which have already demonstrated sensitivity to mutant huntingtin load in animal models. In the current study, the biodistribution and dosimetry of both these ligands will be investigated in young healthy volunteers according to a standard approach, in 3 subjects (including both genders) per tracer.


Description:

For both groups, the dynamic whole-body distribution of the respective tracer labelled with [11C] will be measured after IV administration of 370 MBq. Two venous catheters, one on each arm, will be used for : 1/ the injection of [11C]CHDI-00485180-R or [11C]CHDI-00485626 tracer solution and 2/ for venous blood sampling (blood biochemistry and metabolites). All images will be acquired using the SIEMENS Truepoint Biograph 40 PET-CT scanner. First, a CT scout will be acquired to set the axial field of view (FOV). The axial FOV should extend from the top of the head to the middle of the thighs (approximately 6-7 bed positions). Then, a low dose CT will be acquired for enabling PET attenuation correction and anatomical information (organ delineation). Following the CT, 10 sets of WB 3D PET images in total will be acquired sequentially. The first set of 9 whole body PET scans (scan segment 1) will be acquired, starting at the time of injecting [11C]CHDI-00485180-R solution or [11C]CHDI-00485626 solution. After this sequence of PET acquisitions, which will take up to 100 min, the subject will be moved out of the scanner and will be encouraged to void the bladder. After a 30 minute break, the subject will be repositioned in the PET/CT scanner and a second low dose CT will be acquired. WB scan 10 (scan segment 2) will be started at 2 hours after [11C]CHDI-00485180-R or [11C]CHDI-00485626 injection, scanning for a total scan duration of about 28 minutes. During the first WB PET/CT scan segment, 6 venous blood samples (4 mL each) per subject will be taken at 5, 10, 20, 40, 60 and 100 min after [11C]CHDI-00485180-R or [11C]CHDI-00485626 injection. This will allow testing and further optimization of the HPLC metabolite analysis for future brain imaging studies with full kinetic modelling and quantification.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date October 13, 2020
Est. primary completion date October 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Male or female subjects, age between 18 and 55 years old - Subject is judged to be in good health by the investigator on the basis of medical history. When still in doubt, a full physical and neurological examination can be conducted Exclusion Criteria: - Subject has a history of major internal disease that may interfere with the investigations (especially liver and kidney disease, cancer or uncontrolled diabetes). - Subject has any history of a major neurological or psychiatric disorder - Subject is currently smoker (> 20 cigarettes or equivalent/day) a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse. - Subject has had exposure to ionizing radiation (> 1 mSv) in other research studies within the last 12 months. - Subject suffers from claustrophobia or cannot tolerate confinement during PET-CT scanning procedures; subject cannot lie still for 90 minutes inside the scanner. - Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e. weight lifting, running, bicycling) 3 days before and during the day of scanning. - Subject does not understand the study procedure - Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator. - Subject is potentially pregnant (hCG will be performed in women with childbearing potential). - Allergy for local anesthesia (lidocaine)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
[11C]CHDI-00485180-R
Mutant huntingtin aggregate binding PET radioligand.
[11C]CHDI-00485626
Mutant huntingtin aggregate binding PET radioligand.

Locations

Country Name City State
Belgium UZ Leuven Leuven

Sponsors (2)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven CHDI Foundation, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Normalized cumulated activity coefficients (NCA) Normalized cumulated activity coefficients (MBq-hr/hr) for indicated source organs determined from whole-body imaging. Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
Primary Total organ doses Total organ doses (µGy/MBq) for indicated target organs. Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
Primary Effective doses (ED) Effective doses (µSv/MBq) for indicated target organs. Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
See also
  Status Clinical Trial Phase
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Not yet recruiting NCT04429230 - Non-invasive Brain Stimulation in Huntington's Disease N/A
Recruiting NCT05032196 - Study of WVE-003 in Patients With Huntington's Disease Phase 1/Phase 2
Recruiting NCT03599076 - Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease Huntington's Disease
Terminated NCT04617860 - Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease Phase 1/Phase 2
Completed NCT05748288 - Development of the Virtual Unified Huntington's Disease Rating Scale
Not yet recruiting NCT05360082 - Comparison Between [11C]UCB-J and [18F]SynVest-1 PET in HD.
Not yet recruiting NCT04370470 - Development of Assessments for Later Stage HD
Recruiting NCT01834053 - Safety and Efficacy of Bone Marrow Derived MNCs for Treatment of Cells for the Treatment of Hunting Tons Chorea. Phase 1/Phase 2
Completed NCT01357681 - Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease (ETON-Study) Phase 2
Completed NCT01458470 - A Trial of Memantine as Symptomatic Treatment for Early Huntington Disease Phase 2
Completed NCT00980694 - Bioavailability of Ubiquinol in Huntington Disease Phase 1
Completed NCT00146211 - TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease Phase 3
Recruiting NCT01412125 - Study of Biomarkers That Predict the Evolution of Huntington's Disease N/A
Completed NCT00075140 - Family Health After Predictive Huntington Disease (HD) Testing Phase 3
Recruiting NCT04818060 - Preparing for Prevention of Huntington's Disease (PREVENT-HD)
Active, not recruiting NCT04698551 - NIPD on cffDNA for Triplet Repeat Diseases
Not yet recruiting NCT04301726 - Efficacy of Deutetrabenazine to Control Symptoms of Dysphagia Associated With HD Phase 1
Completed NCT03421327 - Genetic Risk: Whether, When, and How to Tell Adolescents
Recruiting NCT03296176 - Metabolomic Study in Huntington's Disease (METABO-HD) N/A

External Links