Image Guided Adaptive Multi-modality Therapy in the Treatment of Gliomas
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Feasibility of identifying low grade and high grade tumor location with imaging techniques that include MRSI,perfusion MRI, and DTI
研究概览
简要总结
RATIONALE: New imaging techniques using magnetic resonance imaging give better tumor definition, thus may lead to better tumor targeting and avoid damaging critical parts of normal brain.
PURPOSE: This phase I/II trial is studying how well image-guided therapy works in treating patients with newly diagnosed intracranial glioma.
详细描述
PRIMARY OBJECTIVES:
I. To correlate the imaging findings with pathological grade following surgery in patients with newly diagnosed intra-cranial gliomas.
SECONDARY OBJECTIVES:
I. To determine the feasibility of defining the optimal target volume for radiation therapy using MR spectroscopy, diffusion, perfusion and functional imaging. II. To monitor therapeutic responses following treatment using MR spectroscopy, diffusion imaging and perfusion study.
III. To monitor changes in neurocognitive functioning following image guided therapy.
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
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, newly diagnosed intracranial glioma
- •A diagnostic contrast enhanced CT/MRI demonstrating the lesion prior to registration
- •Karnofsky performance status >= 60
- •Ability to undergo MR imaging with the use of Gadolinium dye
- •Patient must sign a study specific informed consent form; if the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative
排除标准
- •Inability to obtain histological proof of glioma
- •Allergy to Gadolinium contrast
- •Any condition including metallic implants or cardiac pace makers that make the candidate ineligible for MR imaging
- •Any medical condition including renal or cardiac insufficiency that make the candidate a high risk for gadolinium contrast administration
- •Karnofsky performance status of =< 50
- •Prior history of radiation therapy to the brain
- •Pregnancy
研究组 & 干预措施
Arm I
Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks.
干预措施: Diffusion-weighted magnetic resonance imaging (Procedure)
Arm I
Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks.
干预措施: Perfusion-weighted magnetic resonance imaging (Procedure)
Arm I
Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks.
干预措施: Functional magnetic resonance imaging (Procedure)
Arm I
Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks.
干预措施: Magnetic resonance spectroscopic imaging (Procedure)
Arm I
Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks.
干预措施: Therapeutic conventional surgery (Procedure)
Arm I
Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks.
干预措施: Quality-of-life assessment (Procedure)
Arm I
Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks.
干预措施: Radiation therapy treatment planning/simulation (Procedure)
Arm I
Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks.
干预措施: Intensity-modulated radiation therapy (Procedure)
Arm I
Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks.
干预措施: Questionnaire administration (Other)
结局指标
主要结局
Feasibility of identifying low grade and high grade tumor location with imaging techniques that include MRSI,perfusion MRI, and DTI
时间窗: Twice a year, after enrollment of first 25 patients, and at study completion
次要结局
- Clinical efficacy of this biological image-guided treatment in gliomas(Twice a year, after enrollment of first 25 patients, and at study completion)
- Incorporate imaging techniques of MRSI, perfusion MRI and DTI into the radiotherapy treatment planning system for target delineation(Twice a year, after enrollment of first 25 patients, and at study completion)