Cryoablation of Brain Neoplasm

Not Applicable

• Conditions: Brain Neoplasm; Brain Metastases; Glioma; Meningioma

• Registration Number: NCT06753617
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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.

Study Timeline

• Study Start: 2023-10-17
• Study First Submitted: 2024-11-15
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-22
• Last Update Submitted: 2024-12-22
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-02
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Assessment of Tumor Cell Ablation: percentage of patients with total resections	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.	The percentage of patients with total resections (percentage of patients who undergo a complete tumor resection).
Assessment of Progression-Free Survival	From enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.	Progression-free survival (PFS) per patient, measured from the date of enrollment to 3 months after enrollment, assessed for disease progression or death.
Assessment of Overall Survival	From enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.	Overall Survival (OS) per patient type at 3 months, measured from the date of enrollment to 3 months after enrollment, assessed for survival (alive or deceased)

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-holland, Netherlands