Role of Neuroinflammation and Blood-Brain Barrier Breakdown in Intracerebral Hemorrhage.

Starting soon · Phase 2

Conditions studied: Intracerebral Hemorrhage

In brief

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.

Key facts

Study ID

NCT07583147

Run by

University Hospital, Toulouse

People needed

117

Starts

2026-06-01

Expected to finish

2029-12-01

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• CHU de Bordeaux — Bordeaux, France
• CHU de montpellier — Montpellier, France
• CHU de Toulouse — Toulouse, France

Full record on ClinicalTrials.gov

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