Cryoablation of Brain Neoplasm

Erasmus University

Status: Invitation-only

Conditions: Glioma; Brain Metastases; Meningioma; Brain Neoplasm

Treatments: Procedure: Cryoablation of brain neoplasm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06753617

NL81429.078.22

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Cryoablation Treatment Group

Experimental group

Description:

All patients enrolled in this study will undergo cryoablation as part of their surgical tumor resection procedure. The intervention will be integrated into the standard surgical approach.

Treatment:

Procedure: Cryoablation of brain neoplasm