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

NCT07583147 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: RC31/24/04432025-521923-58-00
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months

  * 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

  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 Outcomes (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

  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

  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

  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

  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

  o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Mortality is assessed at 6 months.

Study Arms (1)

18F-DPA-714 PET radiotracer uptake within the perihematomal edema

EXPERIMENTAL

18F-DPA-714 injection for TEP

Drug: TEP with 18F-DPA-714 injection

Interventions

TEP with 18F-DPA-714 injection DRUG

TEP with 18F-DPA-714 injection

18F-DPA-714 PET radiotracer uptake within the perihematomal edema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (3)

CHU de Bordeaux

Bordeaux, 33000, France

Location

CHU de montpellier

Montpellier, 34000, France

Location

CHU de Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

tetraethylpyrazine

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nicolas RAPOSO, MD, PHD

CONTACT

05 61 77 76 40; raposo.n@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

FR (3)