NCT00274755已完成2 期
Improved Characterization of Brain Tumors By MRI and MRS
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Time to clinical progression
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI), (done before, during, and after treatment) may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II trial is studying how well MRI and MRSI evaluate patients who are undergoing treatment for gliomas.
详细描述
OBJECTIVES:
- Determine the magnetic resonance spectroscopic imaging (MRSI) characteristics of patients who are undergoing treatment for supratentorial glioma.
- Determine the survival of patients who undergo magnetic resonance imaging and MRSI.
- Determine the clinical outcome of patients who undergo these imaging procedures.
- Correlate measures of metabolic tumor burden (i.e., CNI, CCCrI, CrNI, and LLI) with survival and clinical outcome in patients who undergo these imaging procedures.
- Determine the time to clinical progression in patients who undergo these imaging procedures.
OUTLINE: Patients are assigned to 1 of 2 treatment groups based on grade of disease.
- Group 1 (patients with grade II glioma): Patients undergo magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI). Patients then receive chemotherapy. Patients undergo repeat MRI/MRSI after courses 2 and 4 of chemotherapy.
- Group 2 (patients with grade III-IV glioma): Patients undergo MRI/MRSI and then undergo surgical resection of the tumor. Patients then receive chemoradiotherapy. Patients undergo repeat MRI/MRSI within 2 weeks and at 2 months after completion of radiotherapy.
Patients are followed for recurrence, disease progression, and survival.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Time to clinical progression
Survival
次要结局
未报告次要终点
研究者
研究点 (2)
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