Cryoablation of Brain Neoplasm

Safety and Feasibility of the Use of Cryoablation in Patients With Brain Tumors

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Glioma; Brain Neoplasm; Meningioma; Brain Metastases
• Intervention / Treatment: Procedure: Cryoablation of brain neoplasm

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-holland
    • Rotterdam, Zuid-holland, Netherlands, 3015 GD
      • Erasmus Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cryoablation Treatment Group; 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.

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 will be monitored using intraoperative ultrasound to optimize the ablation process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Incidence and Severity of Complications and Morbidity During the Study Period	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	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	Descriptive: Operation time (in minutes)	From start to end of the procedure, measured in minutes.
Feasibility Evaluation in Blood Loss	Descriptive: Blood loss during intervention (in milliliters)	From start to end of the cryoablation procedure, measured in milliliters.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Arnaud Vincent, MD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: December 22, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Cryoablation; Cryosurgery; Brain neoplasm; Feasibility studies
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Neoplasms; Meningioma; Brain Neoplasms
• Other Study ID Numbers: NL81429.078.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No