By InvitationNot Applicable

Cryoablation of Brain Neoplasm

Netherlands20 participantsStarted 2023-10-17

Plain-language summary

This study will investigate the use of safety and feasibility of cryoablation in brain tumors

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Safety: Incidence and Severity of Complications and Morbidity During the Study Period

Timeframe: 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.

Feasibility Evaluation in Operation Time

Timeframe: From start to end of the procedure, measured in minutes.

Feasibility Evaluation in Blood Loss

Timeframe: From start to end of the cryoablation procedure, measured in milliliters.

Trial details

NCT IDNCT06753617

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02

View on ClinicalTrials.gov More Brain Neoplasm trials