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

Toulouse University Hospital

Status: Withdrawn

Conditions: Ischemic Stroke

Treatments: Other: PET and MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT01866189

11 252 01

Details and patient eligibility

About

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.

Full description

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,

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

PET and MRI

Experimental group

Description:

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.

Treatment:

Other: PET and MRI