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

Not Applicable

Withdrawn

• Conditions: Ischemic Stroke
• Interventions: Other: PET and MRI

• Registration Number: NCT01866189
• Lead Sponsor: University Hospital, Toulouse

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.

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 Timeline

• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-05-31
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-06
• Last Update Posted: 2016-05-09
• Study Start: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET and MRI	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.

Primary Outcome Measures

Name	Time	Method
volume and location of F-MISO uptake in stroke patients	acute phase of brain ischemia < 36 hours

Secondary Outcome Measures

Name	Time	Method
comparison of F-MISO uptake areas and ischemic lesions defined by weighted diffusion and FLAIR on	acute phase of brain ischemia < 36 hours