Ischemic Stroke Clinical Trial
Official title:
Assessment of Hypoxic Tissues in Acute Ischemic Stroke With 18F-FMISOnidazole PET and Comparison With MRI : A Prospective Multicenter Study
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.
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,
;
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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