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

Assessment of Hypoxic Tissues in Acute Ischemic Stroke With 18F-FMISOnidazole PET and Comparison With MRI : A Prospective Multicenter Study

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01866189

Acronym

STROKE F-MISO

Enrollment

Registered

2013-05-31

Start date

2016-09-30

Completion date

2016-10-31

Last updated

2016-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

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

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,

Interventions

OTHERPET and MRI

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
volume and location of F-MISO uptake in stroke patients	acute phase of brain ischemia < 36 hours

Secondary

Measure	Time frame
comparison of F-MISO uptake areas and ischemic lesions defined by weighted diffusion and FLAIR on	acute phase of brain ischemia < 36 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026