Exploratory Study of Cerebral Perfusion and Metabolic Alterations and Neurocognitive Disorders in Patients With Unruptured Arteriovenous Malformations Before and After Surgical Treatment (APEMMAV-NR)
2026년 5월 4일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
10
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Lucas RIBEIRO, Dr
- 전화번호: +33 0467337432
- 이메일: l-ribeiro@chu-montpellier.fr
연구 장소
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France
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Montpellier, France, 프랑스, 34295
- CHU de Montpellier
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연락하다:
- Lucas RIBEIRO, Dr
- 전화번호: +33 0467337432
- 이메일: l-ribeiro@chu-montpellier.fr
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수석 연구원:
- Lucas RIBEIRO, Dr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 실험 부문
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Standardized Uptake Value (SUV)
기간: 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
기간: 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
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Headache impact
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 1일
기본 완료 (추정된)
2028년 11월 1일
연구 완료 (추정된)
2028년 11월 1일
연구 등록 날짜
최초 제출
2026년 4월 21일
QC 기준을 충족하는 최초 제출
2026년 5월 4일
처음 게시됨 (실제)
2026년 5월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 4일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RECHMPL25_0330
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
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아니
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아니
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