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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by University Hospital, Toulouse
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01866189
First received: May 27, 2013
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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 Intervention
Ischemic Stroke
Other: PET and MRI

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • volume and location of F-MISO uptake in stroke patients [ Time Frame: acute phase of brain ischemia < 36 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: TEP

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,
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866189

Contacts
Contact: Jean-François Albucher, MD 05 61 77 76 40 albucher.jf@chu-toulouse.fr
Contact: François Chollet, MD 05 61 77 76 40 chollet.f@chu-toulouse.fr

Sponsors and Collaborators
University Hospital, Toulouse
Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01866189     History of Changes
Other Study ID Numbers: 11 252 01
Study First Received: May 27, 2013
Last Updated: July 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
ischemic stroke
hypoxic tissues
F-MISO uptake
Magnetic Resonance Imaging
F-MISO Positon Emission Tomography

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Ischemia
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014