Dosimetry of [11C]CHDI-180R and [11C]CHDI-626.
Biodistribution and Dosimetry in Human Healthy Volunteers of the Novel PET Radioligands [11C]CHDI-00485180-R and [11C]CHDI-00485626, Designed for Quantification of Cerebral Aggregated Mutant Huntingtin in Huntington's Disease.
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
-
Leuven, België, 3000
- UZ Leuven
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
[11C]CHDI-180R
Biodistribution and whole-body dosimetry for [11C]CHDI-00485180-R in 3 healthy volunteers.
|
Mutant huntingtin aggregate binding PET radioligand.
|
|
[11C]CHDI-626
Biodistribution and whole-body dosimetry for [11C]CHDI-00485626 in 3 healthy volunteers.
|
Mutant huntingtin aggregate binding PET radioligand.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Normalized cumulated activity coefficients (NCA)
Tijdsspanne: Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
|
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)
|
|
Total organ doses
Tijdsspanne: Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
|
Total organ doses (µGy/MBq) for indicated target organs.
|
Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
|
|
Effective doses (ED)
Tijdsspanne: Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
|
Effective doses (µSv/MBq) for indicated target organs.
|
Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
|
Medewerkers en onderzoekers
Medewerkers
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Neurocognitieve stoornissen
- Genetische ziekten, aangeboren
- Basale ganglia-ziekten
- Bewegingsstoornissen
- Neurodegeneratieve ziekten
- Dyskinesieën
- Heredodegeneratieve aandoeningen, zenuwstelsel
- Dementie
- Cognitieve stoornissen
- Chorea
- De ziekte van Huntington
Andere studie-ID-nummers
- s64086
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .