Role of Neuroinflammation and Blood-Brain Barrier Breakdown in Intracerebral Hemorrhage.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TEP with 18F-DPA-714 injection.
- Who it may be relevant to
- Registry conditions: Intracerebral Hemorrhage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Drug TEP with 18F-DPA-714 injection
TEP with 18F-DPA-714 injection
Primary outcome measures
- 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months [Time frame: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH]
Secondary outcome measures (8)
- 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 [Time frame: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH o The functional outcome is measured at 6 months after ICH]
- 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 [Time frame: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Neurological deterioration is assessed within 14 days after ICH onset]
- 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the occurrence of early death [Time frame: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Early death is assessed within 30 days after ICH onset.]
- 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the clinical outcome at 6 months [Time frame: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Clinical outcome is assessed et 6 months]
- 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the mortality [Time frame: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Mortality is assessed at 6 months.]
- 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 [Time frame: PET, MRI and plasma inflammatory biomarkers measures are evaluated at day 10 ±2 after ICH onset]
- BBB breakdown at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months [Time frame: 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.]
- Plasma levels of inflammatory biomarkers at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months [Time frame: o Plasma inflammatory biomarkers measures are assessed at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 3 centers
- CHU de Bordeaux — Bordeaux
- CHU de montpellier — Montpellier
- CHU de Toulouse — Toulouse
Identifiers
NCT: NCT07583147 · RC31/24/0443 · 2025-521923-58-00