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

Primary Purpose

Ischemic Stroke

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PET and MRI
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemic Stroke focused on measuring ischemic stroke, hypoxic tissues, F-MISO uptake, Magnetic Resonance Imaging, F-MISO Positon Emission Tomography

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PET and MRI

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    volume and location of F-MISO uptake in stroke patients

    Secondary Outcome Measures

    comparison of F-MISO uptake areas and ischemic lesions defined by weighted diffusion and FLAIR on

    Full Information

    First Posted
    May 27, 2013
    Last Updated
    May 6, 2016
    Sponsor
    University Hospital, Toulouse
    Collaborators
    Institut National de la Santé Et de la Recherche Médicale, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01866189
    Brief Title
    Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke
    Acronym
    STROKE F-MISO
    Official Title
    Assessment of Hypoxic Tissues in Acute Ischemic Stroke With 18F-FMISOnidazole PET and Comparison With MRI : A Prospective Multicenter Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    default recruitment
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    September 2016 (Anticipated)
    Study Completion Date
    October 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Toulouse
    Collaborators
    Institut National de la Santé Et de la Recherche Médicale, France

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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,

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Stroke
    Keywords
    ischemic stroke, hypoxic tissues, F-MISO uptake, Magnetic Resonance Imaging, F-MISO Positon Emission Tomography

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PET and MRI
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    PET and MRI
    Other Intervention Name(s)
    TEP
    Intervention Description
    F-MISO PET followed by brain MRI (MRI-1)(diffusion, FLAIR, perfusion, TOF)
    Primary Outcome Measure Information:
    Title
    volume and location of F-MISO uptake in stroke patients
    Time Frame
    acute phase of brain ischemia < 36 hours
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

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

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