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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Leuven、ベルギー、3000
- UZ Leuven
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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[11C]CHDI-180R
Biodistribution and whole-body dosimetry for [11C]CHDI-00485180-R in 3 healthy volunteers.
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Mutant huntingtin aggregate binding PET radioligand.
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[11C]CHDI-626
Biodistribution and whole-body dosimetry for [11C]CHDI-00485626 in 3 healthy volunteers.
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Mutant huntingtin aggregate binding PET radioligand.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Normalized cumulated activity coefficients (NCA)
時間枠：Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
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Normalized cumulated activity coefficients (MBq-hr/hr) for indicated source organs determined from whole-body imaging.
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Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
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Total organ doses
時間枠：Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
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Total organ doses (µGy/MBq) for indicated target organs.
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Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
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Effective doses (ED)
時間枠：Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
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Effective doses (µSv/MBq) for indicated target organs.
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Single point measure - during the acquisition of the PET scan (+- 2 hours 30minutes)
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協力者と研究者
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
ハンチントン病の臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
[11C]CHDI-00485180-Rの臨床試験
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CHDI Foundation, Inc.Universitaire Ziekenhuizen KU Leuven終了しました
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Mayo ClinicNational Institute of Neurological Disorders and Stroke (NINDS)募集