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

JRCT ID: jRCT1032220685

Registered date:03/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: asymptomatic intracranial hemangioblastoma in patients with von Hippel-Lindau disease
• Date of first enrollment: 11/12/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Gamma Knife radiosurgery for asymptomatic intracranial hemangioblastomas in Von Hippel-Lindau disease

Outcome(s)

• Primary Outcome: Local control rate at 5 years

Secondary Outcome

(1) Intervention-free survival
(2) Disease specific survival at 5 years
(3) Rate of peritumoral edema after treatment every 6 months
(4) Neurological outcome at 5 years

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hasegawa Hirotaka