Patients indicated for preoperative embolization of intracranial. meningioma,hemangioblastoma,paraganglioma
Conditions
Interventions
Procedure for Intracranial Tumor Embolization Using the Investigational Device (ONYX)
Intracranial tumor embolization using ONYX as the embolic agent shall be performed within 14 days prior to the sch
Sponsors
Sumita Kazutaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be enrolled in this clinical study: 1.Patients scheduled to undergo craniotomy for primary intracranial tumor resection (e.g., meningioma, hemangioblastoma) based on a clinical diagnosis of intracranial tumor. 2.Patients aged 18 years or older at the time of obtaining informed consent. 3.Patients who are independent in activities of daily living prior to surgery (modified Rankin Scale score of 0 to 2). 4.Patients who have provided written informed consent to participate in this clinical study.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from this clinical study: 1.Patients with known allergies to DMSO or EVOH. 2.Patients with significant hepatic dysfunction. 3.Patients with significant renal dysfunction. 4.Patients for whom optimal catheter placement is not feasible. 5.Patients in whom high-flow conditions prevent the safe injection of embolic agents. 6.Patients with vascular spasm resulting in flow obstruction. 7.Patients with recurrent intracranial tumors. 8.Pregnant or lactating women. 9.Patients deemed unsuitable for participation in this study by the principal or sub-investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events and Device Malfunctions Within 30 Days After Craniotomy for Intracranial Tumor Resection | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Reduction rate of contrast-enhanced area of the intracranial tumor on contrast-enhanced MRI after intracranial tumor embolization. 2.Reduction rate of tumor staining area on angiography after intracranial tumor embolization. 3.Intraoperative blood loss during craniotomy for intracranial tumor resection. 4.Duration of surgery for craniotomy for intracranial tumor resection. 5.Length of hospital stay. 6.Simpson grade (for cases of meningioma). 7.Presence or absence of tumor necrosis in histopathological examination of the resected tumor. 8.Presence or absence of ONYX infiltration into intratumoral vessels in histopathological examination of the resected tumor. 9.Recurrence rate at 5 years after craniotomy for intracranial tumor resection. | — |
Contacts
Public ContactSatoru Takahashi
Institute of Science Tokyo Hospital
Outcome results
None listed