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

NCT01866189 | Withdrawn DMC

• 1 other identifier: 11 252 01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemic Stroke

Keywords

ischemic stroke; hypoxic tissues; F-MISO uptake; Magnetic Resonance Imaging; F-MISO Positon Emission Tomography

Outcome Measures

Primary Outcomes (1)

• volume and location of F-MISO uptake in stroke patients

  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

  acute phase of brain ischemia < 36 hours

Study Arms (1)

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.

Other: PET and MRI

Interventions

PET and MRI OTHER

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

Also known as: TEP

PET and MRI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• contraindication to MRI
• comatous status
• \< NIHSS \> 20
• non ischemic stroke
• brainstem stroke

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

MeSH Terms

Conditions

Ischemic Stroke

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; Magnetic Resonance Spectroscopy; tetraethylpyrazine

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: May 31, 2013
• Study Start: September 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 9, 2016

Record last verified: 2016-05