Assessment of Hypoxic Tissues in Acute Ischemic Stroke With 18F-FMISOnidazole PET and Comparison With MRI : A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- volume and location of F-MISO uptake in stroke patients
研究概览
简要总结
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.
详细描述
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,
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •contraindication to MRI
- •comatous status
- •5 < NIHSS > 20
- •non ischemic stroke
- •brainstem stroke
结局指标
主要结局
volume and location of F-MISO uptake in stroke patients
时间窗: acute phase of brain ischemia < 36 hours
次要结局
- comparison of F-MISO uptake areas and ischemic lesions defined by weighted diffusion and FLAIR on(acute phase of brain ischemia < 36 hours)