Cryoablation of Brain Neoplasm

NCT06753617 | Enrolling By Invitation DMC

• 1 other identifier: NL81429.078.22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Brain Neoplasm; Brain Metastases; Glioma; Meningioma

Keywords

Cryoablation; Cryosurgery; Brain neoplasm; Feasibility studies

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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.

• Assessment of Progression-Free Survival

  From enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.

• Assessment of Overall Survival

  From enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.

Study Arms (1)

Cryoablation Treatment Group

EXPERIMENTAL

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

Interventions

Cryoablation of brain neoplasm PROCEDURE

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.

Cryoablation Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<18 years or \>80 years
• Tumor diameter bigger than 10 cm
• Unsafe trajectory (eloquent structures could be damaged)
• Pregnancy
• Contra-indication for general anesthesia

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioma; Meningioma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Study Officials

• Arnaud Vincent, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: December 31, 2024
• Study Start: October 17, 2023
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)