Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke

Study Overview
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Brief Summary
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This study is a French multicenter prospective study including 5 stroke units with available MRI and F-MISO PET for patients with acute ischemic stroke. Background and Purpose: 18F-Fluoromisonidazole (FMISO) PET has been used to identify hypoxic tissues in animals and stroke patients. While MRI has become the gold standard acute stroke imaging, no published study has compared FMISO PET and MRI. The aim of this prospective study is to identify hypoxic tissues in 40 patients with acute ischemic stroke with F-MISO PET and to compare the location and the outcome of these hypoxic cells with MRI datas (weighted diffusion and FLAIR) and to clinical outcome.

Detailed Description
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40 prospective patients (aged 18 to 85 years) will be included in the first 36 hours after ischemic stroke onset. The study period will be 2 years. Included patients will have F-MISO PET followed by brain MRI (MRI-1)(diffusion, FLAIR, perfusion, TOF) as soon as possible after stroke onset (less than 36 hours). A second brain MRI (MRI-2) will be performed on day 7. The aim of the study is to locate hypoxic tissues and to compare with ischemic tissues defined by diffusion and FLAIR MRI sequences, with MRI evolution, and with clinical status at day 7 and day 90. Inclusion criterias Patients aged 18-85 years with encephalic brain ischemic stroke, defined stroke onset, NIHSS 5 to 20, F-MISO Pet and MRI available <36 hours after stroke onset,

Official Title
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Assessment of Hypoxic Tissues in Acute Ischemic Stroke With 18F-FMISOnidazole PET and Comparison With MRI : A Prospective Multicenter Study

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Other: PET and MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-85 years with encephalic brain ischemic stroke, defined stroke onset, NIHSS 5 to 20, F-MISO Pet and MRI available <36 hours after stroke onset, Written consent signed by patient or family Exclusion Criteria: contraindication to MRI comatous status 5 < NIHSS > 20 non ischemic stroke brainstem stroke

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET and MRI<br>Included patients will have F-MISO PET followed by brain MRI (MRI-1)(diffusion, FLAIR, perfusion, TOF) as soon as possible after stroke onset (less than 36 hours). A second brain MRI (MRI-2) will be performed on day 7. | Other: PET and MRI<br>* F-MISO PET followed by brain MRI (MRI-1)(diffusion, FLAIR, perfusion, TOF)<br>* Other names: TEP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume and location of F-MISO uptake in stroke patients |  | acute phase of brain ischemia < 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of F-MISO uptake areas and ischemic lesions defined by weighted diffusion and FLAIR on |  | acute phase of brain ischemia < 36 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, hypoxic tissues, F-MISO uptake, Magnetic Resonance Imaging, F-MISO Positon Emission Tomography