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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
TEP with 18F-DPA-714 injection
DrugTEP with 18F-DPA-714 injection
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
* 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR). Volume of brain tissue (mL) with increased 18F-DPA-714 binding is measured in the area around the hematoma. * 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
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
* 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. * Neurological deterioration within 14 days after ICH onset is defined as a ≥4-point increase on the National Institutes of Health Stroke Scale (NIHSS) or ≥2-point decrease on the Glasgow Coma Scale (GCS) compared to baseline scores at the pre-inclusion visit
18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the occurrence of early death
* 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. * Early death is defined as death at day 30 after ICH onset.
18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the clinical outcome 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. * Clinical outcome at 6 months is assessed by the distribution of modified Rankin scale scores
Sponsors and contacts
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