JPRN-jRCT1032220685招募中2 期
Efficacy and safety of gamma knife radiosurgery for asymptomatic intracranial hemangioblastoma in patients with von Hippel-Lindau disease: A prospective interventional trial
Hasegawa Hirotaka0 个研究点目标入组 20 人开始时间: 2023年3月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 80age old（—）
- 性别
- All
入选标准
- •(1) With a diagnosis of Von Hippel-Lindau (VHL) disease based on clinical criteria of the VHL guideline (2017 edition)
- •(2) With intracranial hemangioblastomas detected by contrast-enhanced MRI without neurological symptoms
- •(3) Aged from 18 to 80 years at the time of informed consent is taken
- •(4) Male or female
- •(5) Able and willing to give written informed consent with sufficient understanding after having received sufficient explanation
- •(6) Able to attend all scheduled visits
排除标准
- •(1) With signs of cerebellar compression, requiring surgery
- •(2) With neurological symptoms
- •(3) With a large tumor, the maximum diameter of the tumor parenchyma of more than 25 mm
- •(4) With a large cystic tumor, the maximum diameter including cystic part of more than 30 mm
- •(5) Having chemotherapy for tumors except brain tumors
- •(6) Karnofsky Performance Score of less than 70
- •(7) With uncontrolled malignancy
- •(8) With severe liver failure or renal failure
- •(9) Unable to have MRI scans
- •(10) With severe abnormality in usual vital signs: systolic blood pressure of 200mmHg or more, diastolic blood pressure of 120 mmHg or more, SpO2 in room air of less than 90%, pulse rate of 120 bpm or more
- •(11) Judged as ineligible by clinical investigators
研究者
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