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Withdrawn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
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
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
NCT ID
NCT01866189
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
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Withdrawn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
Learn more about this trial
Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke
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