Role of Neuroinflammation and Blood-Brain Barrier Breakdown in Intracerebral Hemorrhage. (INFINITE)
2026年5月6日 更新者：University Hospital, Toulouse
In this prospective, multicenter study of patients with acute spontaneous supratentorial Intracerebral Hemorrhage (ICH), each participant will have a standardized multimodal evaluation of neuroinflammation at 10 (±2) days after onset including translocator protein 18 kDa (TSPO) positron emission tomography (PET) using 18F-DPA-714 radioligand, BBB imaging using Dynamic contrast-enhanced (DCE)-MRI and a panel of pro-inflammatory and anti-inflammatory plasma biomarkers.
調査の概要
詳細な説明
Intracerebral Hemorrhage (ICH) is the most devastating stroke subtype that affects > 3 million people worldwide each year. Despite important efforts and the hope that minimally invasive surgical procedures may offer, there is currently no effective treatment. Perihematomal edema - a surrogate marker of neuroinflammation - has emerged as important contributors to poor functional outcome following acute ICH, and a potential treatment target. Innovative techniques have been developed to image and measure neuroimmune response (TSPO PET) and BBB integrity (DCE-MRI). These novel methods have been poorly studied in ICH. The effects of in vivo perihematomal neuroinflammation on the functional outcome of patients with acute ICH is widely unknown.
The present study is a prospective, multicenter study of patients with acute spontaneous supratentorial ICH (within 48h after onset). Each participant will have a standardized multimodal evaluation of neuroinflammation at 10 days after onset including TSPO PET using 18F-DPA-714 radioligand, BBB imaging using DCE-MRI and a panel of pro-inflammatory and anti-inflammatory plasma biomarkers.
In hospital follow up visit will occur at 14 days and end of follow up visit at 180 days. Functional outcome will be assessed by modified Rankin scale (mRS), which is a widely used and validated scale - ranging from 0 (no symptoms) to 6 (death) - to evaluate the functional outcome following ischemic or hemorrhagic strokes.
研究の種類
介入
入学 (推定)
117
段階
- フェーズ2
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：Nicolas RAPOSO, MD, PHD
- 電話番号：33 05 61 77 76 40
- メール：raposo.n@chu-toulouse.fr
研究場所
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Bordeaux、フランス、33000
- CHU de Bordeaux
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コンタクト：
- Igor Sibon, MD, PHD
- 電話番号：33 .5.56.79.55.20
- メール：igor.sibon@chu-bordeaux.fr
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Montpellier、フランス、34000
- CHU de Montpellier
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コンタクト：
- Adrien Ter Schiphorst, MD
- 電話番号：33 .4.67.33.67.33
- メール：adrien.ter.schiphorst@gmail.com
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Toulouse、フランス、31000
- CHU de Toulouse
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コンタクト：
- Nicolas Raposo, MD, PHD
- 電話番号：33 5 61 77 76 40
- メール：raposo.n@chu-toulouse.fr
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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 (≥ 18 years old);
- presenting with a symptomatic spontaneous supratentorial ICH;
- ICH within 48 hours after symptoms onset (or last seen well);
- ICH confirmed by brain imaging;
- Informed consent documented;
- Affiliated or beneficiary of social security scheme.
Exclusion Criteria:
- Massive ICH volume (≥ 60 ml) at admission;
- Severe coma (defined as a Glasgow Coma Scale score < 6) at admission;
- Planned neurosurgical hematoma evacuation;
- Decision already taken for palliative care with withdrawal of active treatment;
- Pre-existing dependance defined as a mRS score ≥2 prior to ICH occurrence;
- Underlying secondary cause of ICH including macrovascular causes (brain arteriovenous malformation, intracranial aneurysm, dural arteriovenous fistula, cavernous malformation), brain tumour, cerebral venous thrombosis, hemorrhagic infarction. Patients taking oral anticoagulant can be included;
- TSPO genotyping demonstrating a low affinity binder profile,
- Unable to tolerate or contraindicated to brain MRI: medical material not MRI compatible, claustrophobia, known hypersensitivity to gadoteric acid, meglumin or any drug containing gadolinium;
- Estimated glomerular filtration rate < 30 ml/min/1.73 m 2
- Unable to tolerate or contraindicated to 18F-DPA714 PET: women who are pregnant or breastfeeding, claustrophobia, and known hypersensitivity to DPA-714;
- Use of Benzodiazepines within 7 days (within 6 weeks for prazepam, diazepam or clorazepate) preceding TSPO PET acquisition;
- Co-existing neuroinflammatory disease such as Multiple Sclerosis, Neuromyelitis optica, Neurosarcoidosis, autoimmune encephalitis, CNS vasculitis;
- Conditions requiring long-term immunosuppressive medication;
- Expected impossible follow-up or poor compliance;
- Patient under tutorship, curatorship, or legal protection.
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：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）
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：18F-DPA-714 PET radiotracer uptake within the perihematomal edema
18F-DPA-714 injection for TEP
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TEP with 18F-DPA-714 injection
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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 |
|---|---|---|
|
18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months
時間枠：o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH
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o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH
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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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Volume of brain tissue with increased 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months
時間枠：o 18F-DPA-714 binding is measured at day 10 ±2 after ICH o The functional outcome is measured at 6 months after ICH
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o 18F-DPA-714 binding is measured at day 10 ±2 after ICH o The functional outcome is measured at 6 months after ICH
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18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the occurrence of neurological deterioration within 14 days after ICH onset
時間枠：o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Neurological deterioration is assessed within 14 days after ICH onset
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o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Neurological deterioration is assessed within 14 days after ICH onset
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18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the occurrence of early death
時間枠：o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Early death is assessed within 30 days after ICH onset.
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o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Early death is assessed within 30 days after ICH onset.
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18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the clinical outcome at 6 months
時間枠：o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Clinical outcome is assessed et 6 months
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o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Clinical outcome is assessed et 6 months
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18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the mortality
時間枠：o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Mortality is assessed at 6 months.
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o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Mortality is assessed at 6 months.
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Correlations of 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH with MRI-derived measures of BBB breakdown and plasma levels of inflammatory biomarkers
時間枠：PET, MRI and plasma inflammatory biomarkers measures are evaluated at day 10 ±2 after ICH onset
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PET, MRI and plasma inflammatory biomarkers measures are evaluated at day 10 ±2 after ICH onset
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BBB breakdown at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months
時間枠：o MRI-derived quantitative measures of BBB breakdown are assessed at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH.
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o MRI-derived quantitative measures of BBB breakdown are assessed at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH.
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Plasma levels of inflammatory biomarkers at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months
時間枠：o Plasma inflammatory biomarkers measures are assessed at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH.
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o Plasma inflammatory biomarkers measures are assessed at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH.
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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6月1日
一次修了 (推定)
2029年9月1日
研究の完了 (推定)
2029年12月1日
試験登録日
最初に提出
2026年1月26日
QC基準を満たした最初の提出物
2026年5月6日
最初の投稿 (実際)
2026年5月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月13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6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。
TEP with 18F-DPA-714 injectionの臨床試験
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University of Alabama at Birmingham引きこもった
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Center Eugene Marquis引きこもった
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Institut Cancerologie de l'OuestSIRIC ILIAD完了