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

Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01866189
• Other study ID #: 11 252 01
• Status: Withdrawn
• Phase: N/A
• First received: May 27, 2013
• Last updated: May 6, 2016
• Start date: September 2016
• Est. completion date: October 2016

Study information

• Verified date: May 2016
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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. 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.

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,

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• PET and MRI
F-MISO PET followed by brain MRI (MRI-1)(diffusion, FLAIR, perfusion, TOF)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Institut National de la Santé Et de la Recherche Médicale, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	volume and location of F-MISO uptake in stroke patients		acute phase of brain ischemia < 36 hours	No
Secondary	comparison of F-MISO uptake areas and ischemic lesions defined by weighted diffusion and FLAIR on		acute phase of brain ischemia < 36 hours	No