Impact of iMRI on the Extent of Resection in Patients With Newly Diagnosed Glioblastomas - A Prospective Multicenter Parallel Group Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 15
- 主要终点
- Complete resections in the postoperative MRI (T1+/-CM) within 48 hours after surgery
研究概览
简要总结
Standard treatment of glioblastomas (GBMs) consists of microsurgical resection followed by concomitant chemoradiation. The extent of resection is one of the most important prognostic factors with significant influence on the survival of patients. State of the art technique to achieve the most radical resection possible in conventional surgery is fluorescence-guidance with 5-aminolevulinic acid (5-ALA). If available, intraoperative MRI (iMRI)-guided tumor resection enables an intraoperative resection control and subsequent continuation of surgery if contrast enhancing tumor remnants are found. Therefore a more radical resection and longer survival of patients might be possible. To date no comparison of these two leading technologies for GBM-surgery is available to identify the best surgical therapy of this fatal disease and to justify significant healthcare-economic differences between both technologies.
Goal of this study is to assess the value of iMRI guidance in the resection of GBMs in comparison to conventional 5-ALA microsurgery. Primary endpoint is the number of total resections (no residual contrast enhancement) in the postoperative MRI (T1+CM within 48 hours after surgery) in each group. Secondary endpoints are perioperative clinical data, progression free survival, patients' clinical condition and overall survival.
The study design was chosen to be a parallel-group approach to compare iMRI and 5-ALA centers (n=13) to exclude possible bias which might be found by randomizing patients within individual iMRI centers and to have surgeons with the most experience possible in use of each respective technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •In MRI suspected primary singular untreated GBM
- •Planned total resection of the tumor according to the surgeon
- •Patient ≥18 years, ≤80 years
- •Preoperative KPS ≥ 60%, American Society of Anesthesiologists (ASA) score 1 and 2
- •Patients' informed consent
排除标准
- •Tumors of the midline, basal ganglia, cerebellum, brain stem, eloquent areas
- •Multifocal glioblastoma
- •Substantial (>50%), non-contrast enhancing tumor areas suggesting low-grade glioma with malignant transformation
- •Contraindications to MRI
- •Inability to give consent because of language barrier or dysphasia
- •Histological diagnosis other than Glioblastoma multiforme WHO °IV
- •Increased risk of thrombosis (e.g. Factor V Leiden)
- •Pregnancy or breast feeding
- •Hypersensibility for 5-ALA oder porphyrins
- •Acute or chronic Porphyria
- •Renal insufficiency
- •Hepatic insufficiency
- •High likelihood of inability to receive adjuvant therapy
研究组 & 干预措施
iMRI-guided surgery
Resection of Glioblastomas with iMRI-guidance
干预措施: iMRI-guided surgery (Device)
5-ALA-guided surgery
Resection of Glioblastomas with 5-ALA-fluorescence-guidance
干预措施: 5-ALA-guided surgery (Drug)
结局指标
主要结局
Complete resections in the postoperative MRI (T1+/-CM) within 48 hours after surgery
时间窗: 48 hour
Completeness of resection in the postoperative MRI within 48h after surgery. Blinded analysis by an independent radiologist.
次要结局
- Histology(1 week after surgery)
- Overall survival (OS)(Day of surgery - Death of patient (Max. 10 years follow-up))
- Patients' clinical condition (NIHSS)(preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery)
- ICU and hospital stay after surgery(Time of hospital stay (average 7days))
- Patients' adjuvant treatment(3Months, 6Months, 9Months, 12Months after surgery)
- MGMT (O6-methylguanine-DNA-methyltransferase) analysis(1 week after surgery)
- Patients' clinical condition (QoL)(preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery)
- Patients' clinical condition (KPS)(preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery)
- Recurrent tumor growth (RANO criteria)(3Months, 6Months, 9Months, 12Months after surgery)
- IDH-1 (isocitrate dehydrogenase) analysis(1 week after surgery)
- Follow-up imaging(3Months, 6Months, 9Months, 12Months after surgery)
- Progression-free survival (PFS)(Day of surgery - 6 months - 12 months)