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Role of Neuroinflammation and Blood-Brain Barrier Breakdown in Intracerebral Hemorrhage.
EU CTIS ID: 2025-521923-58-00
What this study is testing
To evaluate the effect of perihematomal neuroimmune response, assessed by a quantitative measure of 18F-DPA-714 PET radiotracer uptake (binding within PHE) at day 10 ±2 after spontaneous ICH, on the functional outcome (poor versus favorable) at 6 months
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) Adults (≥ 18 years old);
- 2) presenting with a symptomatic spontaneous supratentorial ICH;
- 3) ICH within 48 hours after symptoms onset (or last seen well);
- 4) ICH confirmed by brain imaging;
- 5) Informed consent documented;
- 6) Affiliated or beneficiary of social security scheme
You likely can't join if
- 1) Massive ICH volume (≥ 60 ml) at admission
- 10) Unable to tolerate or contraindicated to 18F-DPA714 PET: women who are pregnant or breastfeeding, claustrophobia, and known hypersensitivity to DPA-714;
- 11) Use of Benzodiazepines within 7 days (within 6 weeks for prazepam, diazepam or clorazepate) preceding TSPO PET acquisition;
- 12) Co-existing neuroinflammatory disease such as Multiple Sclerosis, Neuromyelitis optica, Neurosarcoidosis, autoimmune encephalitis, CNS vasculitis;
- 13) Conditions requiring long-term immunosuppressive medication;
- 14) Expected impossible follow-up or poor compliance;
See the full eligibility criteria
- 1) Adults (≥ 18 years old);
- 2) presenting with a symptomatic spontaneous supratentorial ICH;
- 3) ICH within 48 hours after symptoms onset (or last seen well);
- 4) ICH confirmed by brain imaging;
- 5) Informed consent documented;
- 6) Affiliated or beneficiary of social security scheme
- 1) Massive ICH volume (≥ 60 ml) at admission
- 10) Unable to tolerate or contraindicated to 18F-DPA714 PET: women who are pregnant or breastfeeding, claustrophobia, and known hypersensitivity to DPA-714;
- 11) Use of Benzodiazepines within 7 days (within 6 weeks for prazepam, diazepam or clorazepate) preceding TSPO PET acquisition;
- 12) Co-existing neuroinflammatory disease such as Multiple Sclerosis, Neuromyelitis optica, Neurosarcoidosis, autoimmune encephalitis, CNS vasculitis;
- 13) Conditions requiring long-term immunosuppressive medication;
- 14) Expected impossible follow-up or poor compliance;
- 15) Patient under tutorship, curatorship, or legal protection
- 2) Severe coma (defined as a Glasgow Coma Scale score < 6) at admission;
- 3) Planned neurosurgical hematoma evacuation;
- 4) Decision already taken for palliative care with withdrawal of active treatment;
- 5) Pre-existing dependence defined as a mRS score ≥2 prior to ICH occurrence;
- 6) 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;
- 7) TSPO genotyping demonstrating a low affinity binder profile,
- 8) 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;
- 9) Estimated glomerular filtration rate < 30 ml/min/1.73 m 2;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.