PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Carotid Atherosclerosis
調査の概要
詳細な説明
Objective
Inflammation in the vascular wall plays an important role in the pathophysiology of atherosclerosis, including development of plaque, plaque destabilization and rupture. Clinical and basic scientific data demonstrate the importance of peripheral white blood cells in this process. Therefore, a noninvasive method to detect inflammatory activity in atherosclerosis may be of great value to help determine prognosis, direct therapy and perhaps assess novel therapies for stabilization of atherosclerotic plaque.
The peripheral benzodiazepine receptor (PBR) is distinct from central benzodiazepine receptors associated with GABAA receptors and has been associated with immune function. PBR is expressed in macrophages, therefore, they may be a clinically useful marker to detect inflammation. Our preliminary autoradiographic data demonstrate specific PBR binding in carotid atherosclerosis samples. Though PBR has been imaged in vivo with positron emission tomography (PET) using [(11)C]1-(2-chlorophenyl-N-methylpropyl)-3-isoquinoline carboxamide (PK11195), we developed a new ligand, [(11)C]N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine (PBR28) that shows greater specific signal than [(11)C]PK11195 in non-human primates.
The objective of this protocol is to assess the utility of [(11)C]PBR28 PET to detect inflammation in unstable atherosclerosis plaques and large vessels with inflammation.
Study population
Twenty patients with carotid atherosclerosis, 20 patients with large vessel vasculitis including Takayasu's and Giant Cell arteritis, and 20 age-matched healthy subjects will have one PET scan.
Design
A [(11)C]PBR28 PET scan and a [18 F] fluorodeoxyglucose (FDG) PET scan will be performed in patients with carotid atherosclerosis. If the patient has endarterectomy after the PET scan, endarterectomy samples will be evaluated by in vitro autoradiography using [3H]PK 11195 and immunohistological staining with macrophage markers. Patients with large vessel vasculitis and healthy subjects will also have a [(11)C]PBR28 PET scan [18 F]FDG PET scan.
Outcome measures
Binding of [(11)C]PBR28 in atherosclerotic lesions, aortic arch and its branches will be compared with the binding in the contralateral carotid artery and those in healthy subjects. Binding of [(11)C]PBR28 will also be compared with accumulation of [18 F]FDG in each region. In addition, if the patients with atherosclerosis have endarterectomy, the binding in the atherosclerotic lesions will be compared with immunohistological staining of macrophage markers.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Maryland
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Bethesda、Maryland、アメリカ、20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Bethesda、Maryland、アメリカ、20814
- Suburban Hospital
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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
説明
- INCLUSION CRITERIA
Age 18 - 89
Ability to provide written informed consent
EXCLUSION CRITERIA
Severe systemic disease based on history, physical examination or laboratory tests that would prevent participation in the study
Prior participation in other research protocols in the last year such that radiation exposure would exceed the annual guideline of RSC
Pregnancy and breast feeding
Claustrophobia
Inability to lie flat for a few hours for the PET scans
Medically unstable
The blood glucose level is greater than 150 mg/dL after fasting
Any other condition which in the opinion of the PI would prevent satisfactory participation in and completion of the study.
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
- 主な目的:診断
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
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 |
時間枠 |
|---|---|
|
Binding of [11C]PBR28 at peripheral benzodiazepine receptor
時間枠:3 years
|
3 years
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
PET [F-18]FDG uptake
時間枠:3 years
|
3 years
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Anholt RR, De Souza EB, Oster-Granite ML, Snyder SH. Peripheral-type benzodiazepine receptors: autoradiographic localization in whole-body sections of neonatal rats. J Pharmacol Exp Ther. 1985 May;233(2):517-26.
- Anholt RR, Murphy KM, Mack GE, Snyder SH. Peripheral-type benzodiazepine receptors in the central nervous system: localization to olfactory nerves. J Neurosci. 1984 Feb;4(2):593-603. doi: 10.1523/JNEUROSCI.04-02-00593.1984.
- Schollhammer R, Lepreux S, Barthe N, Vimont D, Rullier A, Sibon I, Berard X, Zhang A, Kimura Y, Fujita M, Innis RB, Zanotti-Fregonara P, Morgat C. In vitro and pilot in vivo imaging of 18 kDa translocator protein (TSPO) in inflammatory vascular disease. EJNMMI Res. 2021 May 5;11(1):45. doi: 10.1186/s13550-021-00786-7.
- Banati RB. Visualising microglial activation in vivo. Glia. 2002 Nov;40(2):206-217. doi: 10.1002/glia.10144.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
本研究に関する用語
その他の研究ID番号
- 080006
- 08-M-0006
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。
[C-11]PBR28の臨床試験
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National Institute of Mental Health (NIMH)完了
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Brigham and Women's HospitalMassachusetts General Hospital募集
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Massachusetts General HospitalGenentech, Inc.完了
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Jennifer WhitwellNational Institute on Aging (NIA)募集皮質基底核変性症 | 皮質基底核症候群 | 皮質基底核変性症 (CBD) | 皮質基底核症候群 (CBS) | 皮質基底核症候群(CBS) | 皮質基底部変性症アメリカ
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Yale UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH)募集健康 | HIV認知症 | HIV関連神経認知障害 | HIV脳炎アメリカ
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Mayo Clinic招待による登録パーキンソン病 | 意味性認知症 | 前頭側頭型認知症の行動バリアント | CBD | 失語症 | MSA - 多系統萎縮症 | FTD | PPA | PSP | PCA | LPA | 意味失語症アメリカ
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Yale UniversityNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)積極的、募集していない