Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesion Using the Tranberg® Thermal Therapy System and Tranberg® Thermoguide Workstation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Device and procedure related adverse events
研究概览
简要总结
This will be an open-label, pilot, exploratory, single centre clinical investigation. This is an early feasibility single arm study. No formal hypothesis is proposed. A total of up to 15 evaluable subjects receiving a non-radical ablation is planned.
The safety and feasibility outcomes will be measured directly post-treatment, 48h and 3 months post-treatment.
A minimal invasive neurosurgical approach with a Magnetic Resonance Imaging (MRI)-based stereotactic guidance system will be utilized for the planning, navigation, intracranial access, placement and confirmation of the Laser applicator prior to ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lesions eligible for Laser Interstitial ThermoTherapy (LITT), target tumor ≤10cc in volume
- •Age ≥ 18 and < 80 years
- •Ability to undergo contrast-enhanced Computed Tomography (CT), Positron Emission Tomography (PET)-CT and contrast-enhanced MRI.
- •Women of childbearing potential must have a negative pregnancy test.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- •Primary glioblastoma/astrocytoma WHO grade IV confirmed by 1)Magnetic Resonance Imaging according to RANO citera and 2)Frozen section biosy diagnosis, and considered not suitable for open surgery or other primary treatment, or Recurrent glioblastoma/astrocytoma WHO grade IV confirmed by Magnetic Resonance Imaging according to RANO criteria.
- •≥3 months since last radiotherapy of the brain
- •Supratentorial tumor localization with or without prior surgery for recurrence.
- •Life expectancy of ≥3 months
- •The subject reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all investigation visits and assessments.
- •Anticipated compliance with treatment and follow-up
排除标准
- •Subject contraindicated for MRI, including subjects who may have contraindications due to implanted medical devices
- •Subject evaluated not to be fit for surgery due to liver/kidney/other organ dysfunction verified by laboratory tests
- •Identified intratumoral cystic or haemorrhagic transformation in target tumor
- •Known bleeding disorder
- •ECOG performance status of >2
- •Previous (within 30 days prior to enrollment / randomization) and concurrent treatment during the treatment phase with other investigational drug/s or device/s
- •Pregnancy or breastfeeding
- •The subject has a cognitive incapacity or language barrier precluding adequate understanding or cooperation
- •The subject is considered by the Investigator to be unsuitable to participate in the investigation for any other reason.
- •Any severe diseases interfering with the performance, evaluation, and outcome of the clinical evaluation
结局指标
主要结局
Device and procedure related adverse events
时间窗: From Day 1 throughout the study until 3 months
The number and severity of adverse events related to the TRANBERG® Laser applicator when used in MR-guided laser thermal ablation of brain lesions
次要结局
- Device and procedure related adverse events(From Day 1 throughout the study until 3 months)