Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke (STROKE F-MISO)
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.
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Assessment of Hypoxic Tissues in Acute Ischemic Stroke With 18F-FMISOnidazole PET and Comparison With MRI : A Prospective Multicenter Study|
- volume and location of F-MISO uptake in stroke patients [ Time Frame: acute phase of brain ischemia < 36 hours ] [ Designated as safety issue: No ]
- comparison of F-MISO uptake areas and ischemic lesions defined by weighted diffusion and FLAIR on [ Time Frame: acute phase of brain ischemia < 36 hours ] [ Designated as safety issue: No ]
|Study Start Date:||September 2016|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: PET and MRI
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
F-MISO PET followed by brain MRI (MRI-1)(diffusion, FLAIR, perfusion, TOF)
Other Name: TEP
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.
- 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,
Please refer to this study by its ClinicalTrials.gov identifier: NCT01866189
|Contact: Jean-François Albucher, MD||05 61 77 76 firstname.lastname@example.org|
|Contact: François Chollet, MD||05 61 77 76 email@example.com|