Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Newly Diagnosed Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 4
- 主要终点
- Adverse Events
研究概览
简要总结
Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System in combination with standard of care radiation therapy and temozolomide for the treatment of newly diagnosed glioblastomas (GBM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven supratentorial GBM that has not undergone previous surgical resection, radiation and/or chemotherapy
- •Single enhancing lesion that is >1 cm, but < 4 cm in cross-sectional dimension, including thalamic tumor (≤ 3 cm)
- •The patient must be ≥18 years of age
- •Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. Patients with prior malignancies must be disease-free for five years.
- •Stable cardiovascular, pulmonary health status
排除标准
- •Seizures occurrence or the requirement of escalation (or addition) of anti-epileptic drugs
- •Symptoms due to mass effect of the tumor including high intracranial pressure, marked edema or ≥5mm midline shift significant
- •Uncontrolled cardiovascular conditions of hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia; or recent history of intracranial hemorrhage
- •Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements
- •Pregnancy, or planning to become pregnant
- •Patients whose physical dimensions cannot be accommodated in the MRI scanner or patients with contraindications to MRI imaging such as pacemakers, non-compatible aneurysm clips, shrapnel and other internal ferromagnetic objects
- •Patients with multiple or multifocal GBM
研究组 & 干预措施
LITT Treatment w/radiation therapy and temozolomide
This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide
干预措施: NeuroBlate System (Device)
LITT Treatment w/radiation therapy and temozolomide
This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide
干预措施: Radiation therapy and temozolomide (Drug)
结局指标
主要结局
Adverse Events
时间窗: 2 Years
Characterize adverse events experienced in glioblastoma subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing.
次要结局
- Progression-Free Survival Rate(2 Years)
- Overall Survival(2 Years)
- Changes in Quality of Life(2 Years)