Huntington DiseaseNCT05224115
Dosimetry of [11C]CHDI-180R and [11C]CHDI-626.
An observational study of Huntington Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease
- What is being tested?
- [11C]CHDI-00485180-R and [11C]CHDI-00485626
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Jul 2020to 13 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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).
Who may be able to join
- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Huntington Disease
- Being tested
- [11C]CHDI-00485180-R, [11C]CHDI-00485626
- Keywords
- Positron Emission Tomography
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]CHDI-00485180-ROther
Mutant huntingtin aggregate binding PET radioligand.
[11C]CHDI-00485626Other
Mutant huntingtin aggregate binding PET radioligand.
| Study group | Role | What they receive |
|---|---|---|
| [11C]CHDI-180R | Biodistribution and whole-body dosimetry for [11C]CHDI-00485180-R in 3 healthy volunteers. Receives: Other: [11C]CHDI-00485180-R | |
| [11C]CHDI-626 | Biodistribution and whole-body dosimetry for [11C]CHDI-00485626 in 3 healthy volunteers. Receives: Other: [11C]CHDI-00485626 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalized cumulated activity coefficients (NCA)
Normalized cumulated activity coefficients (MBq-hr/hr) for indicated source organs determined from whole-body imaging.
Measured: 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.
Measured: Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
Effective doses (ED)
Effective doses (µSv/MBq) for indicated target organs.
Measured: Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start17 Jul 2020
- Primary completion13 Oct 2020
- Study completion13 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- CHDI Foundation, Inc.
- Responsible party
- Sponsor
- Investigators
- Koen Van Laere, MD, PhD, DSc, Principal investigator, UZ/KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224115
- Sponsor's protocol ID
- s64086
- Status last verified
- May 2022
- First submitted
- 13 Jan 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36001116
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05224115
- Acronym / sponsor ID
- s64086
- Conditions
- Huntington Disease
- Keywords
- Positron Emission Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- CHDI Foundation, Inc.
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [11C]CHDI-180R | – | Other: [11C]CHDI-00485180-RBiodistribution and whole-body dosimetry for [11C]CHDI-00485180-R in 3 healthy volunteers. |
| [11C]CHDI-626 | – | Other: [11C]CHDI-00485626Biodistribution and whole-body dosimetry for [11C]CHDI-00485626 in 3 healthy volunteers. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C]CHDI-00485180-RMutant huntingtin aggregate binding PET radioligand. | Other | [11C]CHDI-180R |
| [11C]CHDI-00485626Mutant huntingtin aggregate binding PET radioligand. | Other | [11C]CHDI-626 |
Primary outcome
Normalized cumulated activity coefficients (NCA)
Time frame: 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.
Total organ doses
Time frame: Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
Total organ doses (µGy/MBq) for indicated target organs.
Effective doses (ED)
Time frame: Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
Effective doses (µSv/MBq) for indicated target organs.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Derived from this study: PubMed 36001116Delva 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.
- CHDI foundationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Van Laere, MD, PhD, DSc principal investigator
UZ/KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalized cumulated activity coefficients (NCA) (time frame: Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05224115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.