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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • TEP with 18F-DPA-714 injection

Treatment groups

117 Participants
are divided into 1 treatment group

Locations

3
CHU de Bordeaux33000, Bordeaux France
CHU de montpellier34000, Montpellier France
CHU de Toulouse31000, Toulouse France

Sponsors and collaborators

University Hospital, Toulouse

Lead sponsor