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Efficacy and safety of gamma knife radiosurgery for asymptomatic intracranial hemangioblastoma in patients with von Hippel-Lindau disease: A prospective interventional trial

Phase 2
Recruiting
Conditions
asymptomatic intracranial hemangioblastoma in patients with von Hippel-Lindau disease
asymptomatic 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
Inclusion Criteria

(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

Exclusion Criteria

(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
NameTimeMethod
ocal control rate at 5 years
Secondary Outcome Measures
NameTimeMethod
(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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