MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Time from LITT to adjuvant therapy
研究概览
简要总结
Objective: In preparation of a randomized controlled trial, the investigators aim to assess pilot data on technical feasibility and safety of laser interstitial thermal therapy (LITT) at Radboud University Medical centre and to assess practical feasibility of a randomized study in patients with primary irresectable glioblastoma, as compared with standard of care.
Study design: Prospective randomized pilot study. Randomization stopped (amendment September 2nd, 2021),
Study population: 20 patients aged >= 18 with radiologically suspected diagnosis of primary glioblastoma and contra-indication for surgical resection.
Intervention: Patients will be randomized to receive either (i) biopsy and LITT (n=10) or (ii) biopsy alone (n=10).
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
- •In order to be eligible to participate in the study, a patient must meet all of the following criteria:
- •Informed consent, age >18-year-old
- •Supratentorial localization
- •Maximal volume <=70cc on post-contrast T1 MRI
- •Safe trajectory/trajectories possible for ablation of 70% of the tumour, avoiding eloquent structures or transgression of a ventricle or vessel .
- •Karnofsky Performance Status (KPS) >= 70
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Contra-indication for general anaesthesia or MRI
- •Lesion >70cc on post-contrast MRI on the day before intervention.
- •Non-glioblastoma diagnosis as per frozen section analysis
- •Pregnancy
研究组 & 干预措施
LITT arm
Patients will be randomized to receive biopsy and LITT (n=10)
干预措施: Laser ablation thermal therapy (Procedure)
结局指标
主要结局
Time from LITT to adjuvant therapy
时间窗: 3 months
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Ablation of 90 percent of the target lesion in at least 70 percent of patients
时间窗: 3 months
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
Inclusion rate of patients meeting the inclusion criteria
时间窗: 12 months
To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
Number drop out (informed consent)
时间窗: 30 days
To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
Number of patients with completed follow-up at 3 months
时间窗: 3 months
To assess practical feasibility of a randomized study in this patient population, in preparation of a future randomized controlled trial
30-days mortality
时间窗: 30 days
To assess safety of LITT at our center in patients with irresectable glioblastoma
Number of patients with complications
时间窗: 3 months
To assess safety of LITT at our center in patients with irresectable glioblastoma
Time from inclusion to procedure
时间窗: 3 months
To assess feasibility of LITT at our center in patients with irresectable glioblastoma
次要结局
- Euro quality of life-5D (from 11111, best outcome to 55555 worse outcome)(3 months)
- European Organisation for Research and Treatment of Cancer - BN20 brain module(3 months)
- Tumor volume evolution(3 months)
- Overall survival and progression free survival(12 months)