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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2016-10-31

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.

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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,

Conditions

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Ischemic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PET and MRI

Intervention Type OTHER

F-MISO PET followed by brain MRI (MRI-1)(diffusion, FLAIR, perfusion, TOF)

Interventions

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PET and MRI

F-MISO PET followed by brain MRI (MRI-1)(diffusion, FLAIR, perfusion, TOF)

Intervention Type OTHER

Other Intervention Names

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TEP

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