Cryoablation of Brain Neoplasm

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура 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 wil

Первичные конечные точки

• Safety: Incidence and Severity of Complications and Morbidity During the Study Period [Срок оценки: 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 [Срок оценки: From start to end of the procedure, measured in minutes.]
• Feasibility Evaluation in Blood Loss [Срок оценки: From start to end of the cryoablation procedure, measured in milliliters.]

Вторичные конечные точки (3)

• Assessment of Tumor Cell Ablation: percentage of patients with total resections [Срок оценки: 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 [Срок оценки: From enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.]
• Assessment of Overall Survival [Срок оценки: From enrollment to 3 months after enrollment, with a minimum follow-up of 3 months.]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Нидерланды · 1 центр

• Erasmus Medical Center — Rotterdam

Идентификаторы

NCT: NCT06753617 · NL81429.078.22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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