Constitution of a Standardized Neural Imaging Database in Healthy Subjects
MRI is a powerful imaging tool used for the precise study of brain morphology (morphometric study, tissue study, study of connectivity).
Isotopic examinations by Single Photon Emission Tomography (SPET) and Positron Emission Tomography (PET) are used to explore cerebral perfusion metabolism (99mTc- ECD SPET and 18FDG PET), as well as dopaminergic neurotransmission (123I FP-CIT SPET, DATSCAN®).
These examinations routinely contribute to the clinical diagnosis and surveillance of many neurological pathologies (dementias, Parkinson syndromes, epilepsies, concussions, vascular pathology, brain tumors, etc.).
As a result of the original morphological and functional information they provide, these examinations are being increasingly included in clinical research protocols involving the brain.
The absolute or relative quantification of anomalies observed, however, can be obtained only after comparison to a database of normal subjects.
The creation of these databases is currently limited by their cost and strictly single center nature (physical characteristics of each center's MRI, gamma cameras and PET scanner).
The aim of this multidisciplinary study is to constitute a standardized database of multimode neural imaging (SPET, PET and MRI) to be able to objectively quantify anomalies observed in patients, at the scale of a group or an individual, for the diagnosis and surveillance of neurological diseases.
Participants will be paid €350. 60 healthy subjects between 20 and 80 years of age (30 men and 30 women) will be recruited over 3 years. 4 examinations will be programmed over 2 days (one cerebral MRI, on 18FDG PET, one 99mTc-ECD SPET and one DATSCAN®).
The strictly single center character of this study is explained by the variability of the physical characteristics of the imaging equipment used (MRI, SPET and PET scan) inherent to each center.
調査の概要
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
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-
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Marseille、フランス、13385
- CHU Timone
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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:
- no neurological or psychiatric history
- no serious disease
- receiving no neurotropic
- no alcoholism
- no drug addiction
- social security cover
- written informed consent
Exclusion Criteria:
- pregnancy
- breast feeding
- contraindication to MRI, SPET or PET exploration
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:基礎科学
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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 |
---|---|
precise brain morphology
時間枠:two days
|
two days
|
協力者と研究者
捜査官
- 主任研究者:Eric GUEDJ, AHU、Assistance Publique des Hôpitaux de Marseille
出版物と役立つリンク
一般刊行物
- Mairal E, Barberon B, Laine N, Coulange M, Guedj E. Reversible widespread brain 18F-FDG PET hypometabolism in chronic fatigue syndrome treated by hyperbaric oxygen therapy. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1680-1681. doi: 10.1007/s00259-020-05122-0. Epub 2021 Jan 9. No abstract available.
- Didic M, Felician O, Gour N, Bernard R, Pecheux C, Mundler O, Ceccaldi M, Guedj E. Rhinal hypometabolism on FDG PET in healthy APO-E4 carriers: impact on memory function and metabolic networks. Eur J Nucl Med Mol Imaging. 2015 Sep;42(10):1512-21. doi: 10.1007/s00259-015-3057-y. Epub 2015 Apr 22.
- Arthuis M, Micoulaud-Franchi JA, Bartolomei F, McGonigal A, Guedj E. Resting cortical PET metabolic changes in psychogenic non-epileptic seizures (PNES). J Neurol Neurosurg Psychiatry. 2015 Oct;86(10):1106-12. doi: 10.1136/jnnp-2014-309390. Epub 2014 Dec 2.
研究記録日
主要日程の研究
研究開始
一次修了 (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
- 2007/09
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。
SPET, PET and MRIの臨床試験
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Cambridge University Hospitals NHS Foundation Trust募集
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Turku University HospitalGE Healthcare; Blue Earth Diagnostics完了
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Norwegian University of Science and TechnologyUniversity Hospital of North Norway; Haukeland University Hospital; St. Olavs Hospital募集
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Università Vita-Salute San RaffaeleIRCCS San Raffaele; Associazione Italiana per la Ricerca sul Cancroまだ募集していません乳がんの女性 | 小葉乳癌 | ルミナルA乳がん | ペット/MRI | 腋窩リンパ節症
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)完了
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UNC Lineberger Comprehensive Cancer Center引きこもった