Cryoablation of Brain Neoplasm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cryoablation of brain neoplasm.
- Who it may be relevant to
- Registry conditions: Brain Neoplasm, Brain Metastases, Glioma, Meningioma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety and Feasibility of the Use of Cryoablation in Patients With Brain Tumors
Overview
This study will investigate the use of safety and feasibility of cryoablation in brain tumors
Detailed description
Cryoablation is a therapeutic modality that employs extreme cold to induce cell necrosis in tumor tissue. While the application of cryoablation for the treatment of brain tumors remains under investigation, it has been extensively utilized in other organ systems with outcomes often surpassing those of conventional therapies.
The primary objective of this research is to evaluate the safety and feasibility of cryoablation as a treatment option for patients diagnosed with various brain tumors, including gliomas, meningiomas, and metastatic lesions. Participants enrolled in this study will first undergo standard surgical resection of the brain tumor. Prior to resection, a biopsy of the tumor will be performed to obtain a histopathological diagnosis, ensuring accurate characterization of the tumor type.
Subsequently, the tumor will undergo cryoablation utilizing cryoprobes, with a maximum of two cycles of up to 10 minutes each. The specific number and diameter of cryoprobes used will be determined by the tumor's size, aiming to achieve optimal ablation coverage. Following the removal of the cryoprobes, the tumor will be resected, and standard craniotomy closure procedures will be implemented. Patients will receive standardized postoperative care tailored to their clinical needs.
The follow-up period for this study will extend up to three months following the completion of treatment for the last enrolled participant, allowing for comprehensive assessment of treatment outcomes and safety profiles.
Interventions
- Procedure 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 wil
Primary outcome measures
- Safety: Incidence and Severity of Complications and Morbidity During the Study Period [Time frame: 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 [Time frame: From start to end of the procedure, measured in minutes.]
- Feasibility Evaluation in Blood Loss [Time frame: From start to end of the cryoablation procedure, measured in milliliters.]
Secondary outcome measures (3)
- Assessment of Tumor Cell Ablation: percentage of patients with total resections [Time frame: For progression-free survival and overall survival, the time frame is defined as the period from the date of enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.]
- Assessment of Progression-Free Survival [Time frame: From enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.]
- Assessment of Overall Survival [Time frame: From enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Netherlands · 1 center
- Erasmus Medical Center — Rotterdam
Identifiers
NCT: NCT06753617 · NL81429.078.22