Efficacy and safety of gamma knife radiosurgery for asymptomatic intracranial hemangioblastoma in patients with von Hippel-Lindau disease: A prospective interventional trial
- Conditions
- asymptomatic intracranial hemangioblastoma in patients with von Hippel-Lindau diseaseasymptomatic intracranial hemangioblastoma
- Registration Number
- JPRN-jRCT1032220685
- Lead Sponsor
- Hasegawa Hirotaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ocal control rate at 5 years
- Secondary Outcome Measures
Name Time Method (1) Intervention-free survival<br>(2) Disease specific survival at 5 years<br>(3) Rate of peritumoral edema after treatment every 6 months<br>(4) Neurological outcome at 5 years
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