NCT02006563已完成不适用
Evaluation of Metabolic Tumor Volumes in Radiation of Primary Brain Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Difference between Metabolic Tumor Volumes and Clinical Tumor Volumes in Patients with Brain Tumors
研究概览
简要总结
- Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors.
- If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion is located in the MTV area that is outside of the CTV.
- Alternatively, if CTV > MTV, then the difference in volumes is related to higher treatment toxicity.
详细描述
Metabolic Tumor Volume (MTV), identified by Magnetic Resonance Spectroscopic Imaging (MRSI) is different from the Clinical Target Volume (CTV) used for radiation dose delivery in the treatment of brain tumors.
- If MTV > CTV, the investigators hypothesize that the difference in volumes (cc) is related to worse clinical outcome. Furthermore, in case of local recurrence, the lesion is located in the MTV area that is outside of the CTV.
- Alternatively, if CTV > MTV, then the difference in volumes is related to higher treatment toxicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients must have histologically confirmed primary brain tumor.
- •Patients may be enrolled prior to surgery, after surgical resection or with unresectable tumors.
- •Patients must be 18 years or older.
- •Patients who do not have metal in the body (e.g. pacemakers, implants) that would preclude them from undergoing MRI/MRS exam
- •Patients who do not suffer from claustrophobia (fear of enclosed spaces)
- •Karnofsky performance status ≥
- •Patients whose size would allow them to fit into the bore of the MRI instrument.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients younger than 18 years.
- •Inability to undergo MRI/MRS exam because of metal in the head or body, such as implants, pacemaker, or biostimulation device. Claustrophobia (fear of enclosed spaces).
- •Karnofsky performance status <
- •Patients too large (> 300 lbs.) to fit into the bore of the MRI instrument.
- •Inability to understand the informed consent document.
结局指标
主要结局
Difference between Metabolic Tumor Volumes and Clinical Tumor Volumes in Patients with Brain Tumors
时间窗: 2 years
To evaluate the extent to which tumor volumes, determined by spectroscopic imaging (MTV) differ from the traditionally prescribed clinical treatment volumes (CTV) for radiation therapy
次要结局
未报告次要终点
研究者
Radka S. Stoyanova
Research Associate Professor
University of Miami
研究点 (1)
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