Ireland
--:--IST
Starting soon Phase 2

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

NCT07583147 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2026-06
Last updated
2026-05-13

Condition(s) studied

Intracerebral Hemorrhage

Investigational drug(s) / intervention(s)

TEP with 18F-DPA-714 injection

TEP with 18F-DPA-714 injection: TEP with 18F-DPA-714 injection

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion 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. Exclusion Criteria: 1. Massive ICH volume (≥ 60 ml) at admission; 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 dependance 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 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.

Primary outcome measure(s)

  • 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months — 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 binding is measured by the mean standard uptake value ratio (SUVR) within the perihematomal edema (PHE) using the mirror region of interest (ROI) in the contralateral hemisphere as reference. * The functional outcome at 6 months after ICH is quantified by the modified Rankin scale (which ranges from 0 \[no symptoms\] to 6 \[death\]). Poor functional outcome is defined as a modified Rankin scale score (mRs) ≥3

Trial sites (3)

FacilityCityRegionStatus
CHU de Bordeaux Bordeaux France
CHU de montpellier Montpellier France
CHU de Toulouse Toulouse France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07583147 on ClinicalTrials.gov ↗ ← All trials in France