Exploratory Study of Cerebral Perfusion and Metabolic Alterations and Neurocognitive Disorders in Patients With Unruptured Arteriovenous Malformations Before and After Surgical Treatment (APEMMAV-NR)
2026年5月4日 更新者：University Hospital, Montpellier
The goal of the clinical trial is to describe perfusion and metabolic alterations in different brain regions before and six months after surgical treatment of arteriovenous malformations in adult patients with unruptured arteriovenous malformations.
調査の概要
詳細な説明
Unruptured cerebral arteriovenous malformations are a potentially life-threatening condition and the third leading cause of intracerebral hemorrhage in young adults. Approximately two-thirds of patients with arteriovenous malformations experience a rupture leading to intracranial haemorrhage or develop progressive neurological symptoms or deficits. To date, decisions regarding interventional treatment of unruptured arteriovenous malformations are based on the characteristics of the arteriovenous malformation (size, location, etc.).However, the treatment of these arteriovenous malformations remains controversial in the literature, as the morbidity and mortality associated with intervention may exceed those the malformation's natural history. Furthermore, characteristics of arteriovenous malformations observed during examinations (size, hemodynamic patterns, vascular components) are often insufficient to predict spontaneous evolution, haemorrhagic risk, and associated symptoms.
Studies suggest that neurological symptoms may be linked to impaired cerebral perfusion and metabolism, particularly through hypoperfusion in the peri-arteriovenous malformation region or peri-lesional oedema. However, the results of these previous studies remain limited and of little significance.
The proposed project aims to establish a cohort over a 16-month period in order to study in detail the metabolic and perfusion alterations associated with arteriovenous malformations, as well as their neurocognitive and psychological impacts, with the aim of improving the pathophysiology understanding and treatment of these malformations.
研究の種類
介入
入学 (推定)
10
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Lucas RIBEIRO, Dr
- 電話番号：+33 0467337432
- メール：l-ribeiro@chu-montpellier.fr
研究場所
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France
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Montpellier、France、フランス、34295
- CHU de Montpellier
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コンタクト：
- Lucas RIBEIRO, Dr
- 電話番号：+33 0467337432
- メール：l-ribeiro@chu-montpellier.fr
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主任研究者：
- Lucas RIBEIRO, Dr
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Adults aged 18 and older
- Admitted for an unruptured arteriovenous malformation with a decision to proceed with surgery
Exclusion Criteria:
- Patients who refuse surgical treatment for arteriovenous malformation
- Contraindications to 18F-FDG PET (uncontrolled diabete)
- Patients' inability to lie still for 40 minutes
- Patients with a confirmed diagnosis of neurodegenerative or psychiatric disorders
- Pregnant or breastfeeding women (Article L.1121-5 of the French Public Health Code)
- Persons deprived of their liberty by judicial or administrative decision (Article L.1121-6 of the French Public Health Code)
- Persons who are subject to legal protection measures or who are unable to express their consent (guardianship, curatorship, judicial protection; Article L.1121-8 of the French Public Health Code)
- Not affiliated with a social security scheme or beneficiary of such a scheme (Article L.1121-8-1 of the French Public Health Code)
- Persons participating in another study that includes an ongoing exclusion period (Article L.1121-12 of the French Public Health Code)
- Failure to obtain written informed consent
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：他の
- 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）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：実験アーム
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For the 18F-FDG (fluorodeoxyglucose labelled with fluorine-18) PET scan, a dynamic protocol with the radiopharmaceutical injected directly under the scanner. The dose injected will be the same as that used in routine clinical practice, i.e. calculated based on the patient's weight. The patient must fast for 6 hours prior to the examination. The total duration of the dynamic PET scan is estimated at approximately 1 hour 30 minutes.
For the neuropsychological assessment, a series of standardised tests, validated for the assessment of cognitive functions, will be administered.
This assessment will be carried out by neuropsychologists trained in the use of these tests and who administer them as part of their routine practice, or by a trained physiatrist specialising in disorders of the central nervous system.
The neuropsychological assessment is expected to take 2 to 3 hours per visit for the patient.
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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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Change in Standardized Uptake Value (SUV)
時間枠：Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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Changes in Standardized Uptake Value (SUV) measured by 18F-FDG positron emission tomography (PET) in different brain regions (arteriovenous malformation region, arteriovenous malformation hemisphere including the arteriovenous malformation region, arteriovenous malformation hemisphere excluding the arteriovenous malformation region, contralateral hemisphere)
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Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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Change in K1 Transfer Constant
時間枠：Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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Change in the K1 transfer constant, representing the transfer of the tracer from the plasma compartment to the tissue compartment, measured by 18F-FDG positron emission tomography (PET) measured in different brain regions (arteriovenous malformation region, arteriovenous malformation hemisphere including the arteriovenous malformation region, arteriovenous malformation hemisphere excluding the arteriovenous malformation region, contralateral hemisphere).
Unit : mL.g-1.min-1
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Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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Change in Ki Net Influx Rate Constant
時間枠：Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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Change in Ki net influx rate constant measured by 18F-FDG positron emission tomography (PET) in different brain regions (arteriovenous malformation region, arteriovenous malformation hemisphere including the arteriovenous malformation region, arteriovenous malformation hemisphere excluding the arteriovenous malformation region, contralateral hemisphere).
Unit : mL.g-1.min-1
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Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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Change in Cerebral Metabolic Rate of glucose (CMRglu)
時間枠：Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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Change in cerebral metabolic rate of glucose (CMRglu) measured by 18F-FDG positron emission tomography (PET) in different brain regions (arteriovenous malformation region, arteriovenous malformation hemisphere including the arteriovenous malformation region, arteriovenous malformation hemisphere excluding the arteriovenous malformation region, contralateral hemisphere).
Unit : µmol.100g-¹.min-¹
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Before and at 6 months after surgical treatment of unruptured arteriovenous malformation
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Headache impact
時間枠：Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Headache impact assessed by the total score on the Headache Impact Test - 6 items (HIT-6) Total score between 36 and 78.
A higher score indicates a greater functional impact.
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Visual attention and processing speed
時間枠：Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Visual attention and processing speed assessed by completion time on the Trail Making Test - Part A (TMT-A)
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Cognitive flexibility and executive control
時間枠：Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Cognitive flexibility and executive control assessed by completion time on the Trail Making Test - Part B (TMT-B)
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Inhibition and selective attention
時間枠：Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Inhibition and selective attention assessed by completion times and number of errors on the Stroop Test
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Working memory
時間枠：Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Working memory assessed by scores on the Digit Span subtest of the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV)
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Global verbal episodic memory
時間枠：Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Global verbal episodic memory assessed by scores on the 16-item Free Recall / Cued Recall test (RL/RI-16)
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Phonemic and semantic verbal fluency
時間枠：Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Phonemic and semantic verbal fluency assessed by the number of words produced on verbal fluency tests
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Ecological executive functioning
時間枠：Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Ecological executive functioning assessed by raw scores and composite indices on the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Visual constructive abilities and visual memory
時間枠：Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Visual constructive abilities and visual memory assessed by scores on the Rey-Osterrieth Complex Figure Test
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Visual attention and spatial exploration
時間枠：Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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Visual attention and spatial exploration assessed by the number of crossed-out targets, omissions, and their spatial distribution in the Bell Test.
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Before, at 3 months and 6 months after surgical treatment of unruptured arteriovenous malformation
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月1日
一次修了 (推定)
2028年11月1日
研究の完了 (推定)
2028年11月1日
試験登録日
最初に提出
2026年4月21日
QC基準を満たした最初の提出物
2026年5月4日
最初の投稿 (実際)
2026年5月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月6日
QC基準を満たした最後の更新が送信されました
2026年5月4日
最終確認日
2026年5月1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。
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