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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01866189

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Enrollment

Arm

Duration (Days)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Other: PET and MRI	N/A

Detailed 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,

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2016

Anticipated Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: TEP

Arm

Intervention/Treatment

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 Names:

TEP