N,N-DIETHYL-(2-(4-(2-(18F)FLUOROETHOXY)PHENYL)-5,7-DIMETHYLPYRAZOLO(1,5-A)PYRIMIDINE-3-YL)ACETAMIDE for Intracerebral hemorrhage

Inclusion criteria

• {"criterion_text":"- 1)\tAdults (≥ 18 years old);\n- 2)\tpresenting with a symptomatic spontaneous supratentorial ICH;\n- 3)\tICH within 48 hours after symptoms onset (or last seen well);\n- 4)\tICH confirmed by brain imaging;\n- 5)\tInformed consent documented;\n- 6)\tAffiliated or beneficiary of social security scheme"}

Exclusion criteria

• {"criterion_text":"- 1)\tMassive ICH volume (≥ 60 ml) at admission\n- 10)\tUnable to tolerate or contraindicated to 18F-DPA714 PET: women who are pregnant or breastfeeding, claustrophobia, and known hypersensitivity to DPA-714;\n- 11)\tUse of Benzodiazepines within 7 days (within 6 weeks for prazepam, diazepam or clorazepate) preceding TSPO PET acquisition;\n- 12)\tCo-existing neuroinflammatory disease such as Multiple Sclerosis, Neuromyelitis optica, Neurosarcoidosis, autoimmune encephalitis, CNS vasculitis;\n- 13)\tConditions requiring long-term immunosuppressive medication;\n- 14)\tExpected impossible follow-up or poor compliance;\n- 15)\tPatient under tutorship, curatorship, or legal protection\n- 2)\tSevere coma (defined as a Glasgow Coma Scale score < 6) at admission;\n- 3)\tPlanned neurosurgical hematoma evacuation;\n- 4)\tDecision already taken for palliative care with withdrawal of active treatment;\n- 5)\tPre-existing dependence defined as a mRS score ≥2 prior to ICH occurrence;\n- 6)\tUnderlying 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;\n- 7)\tTSPO genotyping demonstrating a low affinity binder profile,\n- 8)\tUnable to tolerate or contraindicated to brain MRI: medical material not MRI compatible, claustrophobia, known hypersensitivity to gadoteric acid, meglumin or any drug containing gadolinium;\n- 9)\tEstimated glomerular filtration rate < 30 ml/min/1.73 m 2;"}

Primary endpoints

• {"endpoint_text":"- o\t18F-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","definition_or_measurement_approach":"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 (quantitative PET measure)."}
• {"endpoint_text":"- o\tThe 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","definition_or_measurement_approach":"Assessed by the modified Rankin scale (mRS) at 6 months; poor functional outcome defined as mRS ≥3."}

Secondary endpoints

• {"endpoint_text":"- o\tVolume of brain tissue within the perihematomal area with increased 18F-DPA-714 binding","definition_or_measurement_approach":"Volume measurement of brain tissue in perihematomal area showing increased 18F-DPA-714 uptake (PET-derived volumetric measure)."}
• {"endpoint_text":"- o\tvoxel-wise 18F-DPA-714 levels based on SuperVised Cluster Analysis (SVCA).","definition_or_measurement_approach":"Voxel-wise PET quantification of 18F-DPA-714 using SuperVised Cluster Analysis (SVCA)."}
• {"endpoint_text":"- The associations of PET-derived quantitative measures of 18F-DPA-714 radiotracer uptake with: o\tNeurological deterioration within 14 days after ICH onset, defined as a ≥4‐point increase on the National Institutes of Health Stroke Scale (NIHSS) or ≥2‐point decrease on the Glasgow Coma Scale compared to baseline scores at the pre-inclusion visit;","definition_or_measurement_approach":"Neurological deterioration defined as ≥4-point increase on NIHSS or ≥2-point decrease on GCS within 14 days compared to baseline; associations tested with PET quantitative metrics."}
• {"endpoint_text":"- o\tEarly death defined as death at day 30","definition_or_measurement_approach":"Early death = death by day 30; association with PET measures assessed."}
• {"endpoint_text":"- o\tClinical outcome at 6 months assessed by the distribution of modified Rankin scale scores","definition_or_measurement_approach":"Distribution of mRS scores at 6 months compared/associated with PET measures."}
• {"endpoint_text":"- o\tMortality at 6 months","definition_or_measurement_approach":"All-cause mortality at 6 months."}
• {"endpoint_text":"- o\tMRI-derived quantitative measures of BBB breakdown (based on maps of the contrast agent transfer coefficient, Ktrans) in the perihematomal area at day 10 ±2 after ICH","definition_or_measurement_approach":"MRI-derived Ktrans maps quantify blood-brain barrier breakdown in perihematomal area at day 10 ±2."}
• {"endpoint_text":"- o\tPlasma levels of inflammatory biomarkers (including MMP9, TNF alpha, IL-6 and -10, soluble TLR 2/4, Neutrophil Extracellular Traps –(NETs)) at day 10 ±2 after ICH onset","definition_or_measurement_approach":"Plasma biomarker panel measured at day 10 ±2, including MMP9, TNF-α, IL-6, IL-10, soluble TLR2/4, NETs."}
• {"endpoint_text":"- \tThe comparison of MRI-derived quantitative measures of BBB breakdown and plasma levels of inflammatory biomarkers between patients with poor vs favorable functional outcome at 6 months","definition_or_measurement_approach":"Comparative analysis of MRI-derived Ktrans and plasma biomarkers between groups defined by 6-month functional outcome (poor vs favorable)."}
• {"endpoint_text":"- \tPerformance of PET-derived quantitative measures of 18F-DPA-714 radiotracer uptake, MRI-derived quantitative measures of BBB breakdown, and plasma levels of inflammatory biomarkers to predict the functional outcome at 6 months, assessed by receiver operating characteristic (ROC) curve analyses and area under curve (AUC) values","definition_or_measurement_approach":"Predictive performance evaluated using ROC curve analyses and AUC for PET, MRI (Ktrans) and plasma biomarkers to predict 6-month outcome."}
• {"endpoint_text":"- \tThe associations of baseline clinical and imaging variables with: o\tPET-derived quantitative measure of 18F-DPA-714 PET radiotracer uptake o\tMRI-derived quantitative measures of BBB breakdown","definition_or_measurement_approach":"Association analyses between baseline clinical/imaging variables and PET-derived uptake metrics and MRI-derived BBB measures."}

France

Earliest CTIS Part Ii Submission Date

12-09-2025

Latest Decision Or Authorization Date

10-10-2025

Processing Time Days

28

Number Of Sites

3

Number Of Participants

117

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Toulouse

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"French National Research Agency (ANR)","duties_or_roles":"Funding","organisation_type":""}