Intracranial lesions, Brain tumor, Inoperable or recurrent gliomas (astrocytoma, oligodendroglioma, glioblastoma), Meningiomas (WHO grade I-III), Brain metastases, Vascular lesions (cavernomas and hemangioblastomas). Tumors of glial cells in the brain (gliomas), Tumors arising from the membranes covering the brain (meningiomas), Cancer cells that have spread to the brain from elsewhere in the body (brain metastases), and abnormal clusters of blood vessels in the brain (vascular lesions).
Conditions
Interventions
The investigational intervention is minimally invasive cryoablation, in which various types of brain tumors with contraindications for resection are frozen using a cryoprobe following a biopsy, withou
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:Age =18 years.Tumor suspected as (recurrent) glioma (1. Astrocytoma, IDH mutant 2. Oligodendroglioma, IDH- mutant and 1p/19q-codeleted 3. Glioblastoma, IDH-wildtype), meningioma (primary or recurrent, WHO I-III), brain metastasis (primary or recurrent), and vascular lesions (cavernomas or hemangioblastomas) on diagnostic MRI.Deep-seated , multifocal or inoperable tumors (e.g., thalamus, insula, corpus callosum) that are not amenable to open surgical resection but only biopsy due to high risk of neurological damage, or other contraindications such as comorbidities.Supratentorial or infratentorial localization.Tumor max diameter < 10 cm and brain shift < 4 cm.Patients must have KPS = 70, indicating they are functionally independent.Safe trajectory/trajectories possible for ablation of at least 70% of the tumor.Sufficient knowledge of the Dutch language to understand the study documents (in the judgement of the attending physician or researcher).Written Informed consent.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:<18 years Tumor diameter >10 cmUnsafe trajectory (eloquent structures could be damaged)PregnancyContra-indication for general anesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are the incidence of peri-/postoperative complications (seizures, neurological deficits, wound infections, intracranial hemorrhage, brain edema, steroid dependence, procedure-related mortality) and the need for neurosurgical intervention during the follow-up due to complications or treatment failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters include radiographic tumor response (RANO criteria), overall survival (OS), progression-free survival (PFS) in months, quality of life, and cognitive function during the follow-up period in addition procedural efficiency (operative time, hospital stay, readmission rate during the follow-up). | — |
Countries
Netherlands
Contacts
Public ContactS. Mohammadian
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed