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Enrolling by Invitation

NCT Number: NCT06753617

Cryoablation of Brain Neoplasm

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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

  2. Feasibility Evaluation in Operation Time

    Time frame: From start to end of the procedure, measured in minutes.

    Descriptive:

    Operation time (in minutes)

  3. Feasibility Evaluation in Blood Loss

    Time frame: From start to end of the cryoablation procedure, measured in milliliters.

    Descriptive:

    Blood loss during intervention (in milliliters)

Secondary outcomes

  1. 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.

    The percentage of patients with total resections (percentage of patients who undergo a complete tumor resection).

  2. Assessment of Progression-Free Survival

    Time frame: 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.

  3. Assessment of Overall Survival

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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