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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521923-58-00 | EU Trial (CTIS) Number |
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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.
Intracerebral Hemorrhage (ICH) is the most devastating stroke subtype that affects > 3 million people worldwide each year. Despite important efforts and the hope that minimally invasive surgical procedures may offer, there is currently no effective treatment. Perihematomal edema - a surrogate marker of neuroinflammation - has emerged as important contributors to poor functional outcome following acute ICH, and a potential treatment target. Innovative techniques have been developed to image and measure neuroimmune response (TSPO PET) and BBB integrity (DCE-MRI). These novel methods have been poorly studied in ICH. The effects of in vivo perihematomal neuroinflammation on the functional outcome of patients with acute ICH is widely unknown.
The present study is a prospective, multicenter study of patients with acute spontaneous supratentorial ICH (within 48h after onset). Each participant will have a standardized multimodal evaluation of neuroinflammation at 10 days after onset including TSPO PET using 18F-DPA-714 radioligand, BBB imaging using DCE-MRI and a panel of pro-inflammatory and anti-inflammatory plasma biomarkers.
In hospital follow up visit will occur at 14 days and end of follow up visit at 180 days. Functional outcome will be assessed by modified Rankin scale (mRS), which is a widely used and validated scale - ranging from 0 (no symptoms) to 6 (death) - to evaluate the functional outcome following ischemic or hemorrhagic strokes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-DPA-714 PET radiotracer uptake within the perihematomal edema | Experimental | 18F-DPA-714 injection for TEP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEP with 18F-DPA-714 injection | Drug | TEP with 18F-DPA-714 injection |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas RAPOSO, MD, PHD | Contact | 05 61 77 76 40 | 33 | raposo.n@chu-toulouse.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33000 | France |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C072829 | tetraethylpyrazine |
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| 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. |
| Correlations of 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH with MRI-derived measures of BBB breakdown and plasma levels of inflammatory biomarkers |
| PET, MRI and plasma inflammatory biomarkers measures are evaluated at day 10 ±2 after ICH onset |
| BBB breakdown at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months |
| o MRI-derived quantitative measures of BBB breakdown are assessed at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH. |
| Plasma levels of inflammatory biomarkers at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months |
| o Plasma inflammatory biomarkers measures are assessed at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH. |
| CHU de montpellier | Montpellier | 34000 | France |
|
| CHU de Toulouse | Toulouse | 31000 | France |
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |