Cryoablation of brain neoplasm: The procedure begins with standard surgical exposure of the tumor, followed by a biopsy. Next, one or more cryoprobes will be positioned directly into the tumor for ablation. Once positioned, the cryoablation process will commence. A maximum of 2x10 minutes cryoablation cycles will be established followed by active thawing. Following ablation, resection of the tumor will be performed, after which patients will receive standard treatment and follow-up care. Ice formation around the cryoprobes will be monitored using intraoperative ultrasound to optimize the ablation process.
Study summary
This study will investigate the use of safety and feasibility of cryoablation in brain tumors
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Age \>18 years
* Tumor suspected as glioma (1. Astrocytoma, IDH mutant 2. Oligodendroglioma, IDH-mutant and 1p/19q-codeleted 3. Glioblastoma, IDH-wildtype), meningioma (WHO gr. 1 and gr 2), or brain metastasis based on preliminary diagnosis for which the patient will undergo surgery
* Supratentorial or infratentorial localization
* Safe trajectory/trajectories possible for ablation of at least 70% of the tumor, avoiding eloquent structures
* Karnofsky performance scale 70 or more
* 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:
* \<18 years or \>80 years
* Tumor diameter bigger than 10 cm
* Unsafe trajectory (eloquent structures could be damaged)
* Pregnancy
* Contra-indication for general anesthesia
Primary outcome measure(s)
Safety: Incidence and Severity of Complications and Morbidity During the Study Period — From enrollment to the end of the study, with a minimum follow-up of 3 months. Complications such as bleeding, infection, epilepsy, brain edema, neurological deficit, and death will be evaluated, with safety assessed up to 12 months post-surgery. Complications \& morbidity during the entire study period as decided by the treating physician. Severity and frequency of the following complications:
* Postoperative intracranial bleeding
* Wound infection
* Epilepsy
* Brain edema
* Neurological deficit (paresis/plegia)
* Aphasia
* Death
Feasibility Evaluation in Operation Time — From start to end of the procedure, measured in minutes. Descriptive:
Operation time (in minutes)
Feasibility Evaluation in Blood Loss — From start to end of the cryoablation procedure, measured in milliliters. Descriptive:
Blood loss during intervention (in milliliters)
Trial sites (1)
Facility
City
Region
Status
Erasmus Medical Center
Rotterdam
South Holland
More Erasmus Medical Center trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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