Ischemic StrokeSTROKE F-MISONCT01866189
Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke
A study testing PET and MRI in people with Ischemic Stroke, run by University Hospital, Toulouse.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- PET and MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- contraindication to MRI
- comatous status
- 5 < NIHSS > 20
- non ischemic stroke
- brainstem stroke
About this study
Official title: 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.
Read the 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,
- Conditions
- Ischemic Stroke
- Being tested
- PET and MRI
- Keywords
- ischemic stroke, hypoxic tissues, F-MISO uptake, Magnetic Resonance Imaging, F-MISO Positon Emission Tomography
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET and MRIOther
Also called TEP
F-MISO PET followed by brain MRI (MRI-1)(diffusion, FLAIR, perfusion, TOF)
| Study group | Role | What they receive |
|---|---|---|
| PET and MRI | Experimental | 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. Receives: Other: PET and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume and location of F-MISO uptake in stroke patients
Measured: acute phase of brain ischemia < 36 hours
Secondary outcomes (1)
comparison of F-MISO uptake areas and ischemic lesions defined by weighted diffusion and FLAIR on
Measured: acute phase of brain ischemia < 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startSep 2016
- Primary completionSep 2016 (estimated)
- Study completionOct 2016 (estimated)
Why it stopped: default recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866189
- Sponsor's protocol ID
- 11 252 01
- Acronym
- STROKE F-MISO
- Status last verified
- May 2016
- First submitted
- 27 May 2013
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hypoxic Tissues in Acute Ischemic Stroke With 18F-FMISOnidazole PET and Comparison With MRI : A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT01866189
- Acronym / sponsor ID
- STROKE F-MISO / 11 252 01
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, hypoxic tissues, F-MISO uptake, Magnetic Resonance Imaging, F-MISO Positon Emission Tomography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: default recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Sep 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET and MRI | Experimental | Other: PET and MRIIncluded 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- contraindication to MRI
- comatous status
- 5 < NIHSS > 20
- non ischemic stroke
- brainstem stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET and MRIAlso: TEPF-MISO PET followed by brain MRI (MRI-1)(diffusion, FLAIR, perfusion, TOF) | Other | PET and MRI |
Primary outcome
volume and location of F-MISO uptake in stroke patients
Time frame: acute phase of brain ischemia < 36 hours
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PET and MRI in people with Ischemic Stroke, run by University Hospital, Toulouse.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume and location of F-MISO uptake in stroke patients (time frame: acute phase of brain ischemia < 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.