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.
1 other identifier
observational
6
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 13, 2020
CompletedFirst Submitted
Initial submission to the registry
January 13, 2022
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedMay 19, 2022
May 1, 2022
3 months
January 13, 2022
May 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
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)
Effective doses (ED)
Effective doses (µSv/MBq) for indicated target organs.
Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
Study Arms (2)
[11C]CHDI-180R
Biodistribution and whole-body dosimetry for \[11C\]CHDI-00485180-R in 3 healthy volunteers.
[11C]CHDI-626
Biodistribution and whole-body dosimetry for \[11C\]CHDI-00485626 in 3 healthy volunteers.
Interventions
Eligibility Criteria
6 young (18-55 years), healthy subjects, 3 for panel A (\[11C\]CHDI-00485180-R) and 3 for panel B \[(11C\]CHDI-00485626). Each panel should include both genders (i.e., 2M/1F or 2F/1M).
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitaire Ziekenhuizen KU Leuvenlead
- CHDI Foundation, Inc.collaborator
Study Sites (1)
UZ Leuven
Leuven, 3000, Belgium
Related Publications (1)
Delva A, Koole M, Serdons K, Bormans G, Liu L, Bard J, Khetarpal V, Dominguez C, Munoz-Sanjuan I, Wood A, Skinbjerg M, Wang Y, Vandenberghe W, Van Laere K. Biodistribution and dosimetry in human healthy volunteers of the PET radioligands [11C]CHDI-00485180-R and [11C]CHDI-00485626, designed for quantification of cerebral aggregated mutant huntingtin. Eur J Nucl Med Mol Imaging. 2022 Dec;50(1):48-60. doi: 10.1007/s00259-022-05945-z. Epub 2022 Aug 24.
PMID: 36001116DERIVED
Related Links
Biospecimen
* 2 urine samples for radio-activity assessments (3th sample prior to scanning for female participants for pregnancy test) * 6 venous blood samples for metabolite analysis
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Koen Van Laere, MD, PhD, DSc
UZ/KU Leuven
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2022
First Posted
February 4, 2022
Study Start
July 17, 2020
Primary Completion
October 13, 2020
Study Completion
October 13, 2020
Last Updated
May 19, 2022
Record last verified: 2022-05