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

May 6, 2016 updated by: University Hospital, Toulouse

Assessment of Hypoxic Tissues in Acute Ischemic Stroke With 18F-FMISOnidazole PET and Comparison With MRI : A Prospective Multicenter Study

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
volume and location of F-MISO uptake in stroke patients
Time Frame: acute phase of brain ischemia < 36 hours
acute phase of brain ischemia < 36 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
acute phase of brain ischemia < 36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

May 27, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (Estimate)

May 31, 2013

Study Record Updates

Last Update Posted (Estimate)

May 9, 2016

Last Update Submitted That Met QC Criteria

May 6, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11 252 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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