Department of Neursurgery, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
BMJ Open. 2022 Nov 15;12(11):e064823. doi: 10.1136/bmjopen-2022-064823.
Surgery remains the mainstay for treatment of primary glioblastoma, followed by radiotherapy and chemotherapy. Current standard of care during surgery involves the intraoperative use of image-guidance and 5-aminolevulinic acid (5-ALA). There are multiple other surgical adjuncts available to the neuro-oncology surgeon. However, access to, and usage of these varies widely in UK practice, with limited evidence of their use. The aim of this trial is to investigate whether the addition of diffusion tensor imaging (DTI) and intraoperative ultrasound (iUS) to the standard of care surgery (intraoperative neuronavigation and 5-ALA) impacts on deterioration free survival (DFS).
This is a two-stage, randomised control trial (RCT) consisting of an initial non-randomised cohort study based on the principles of the IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) stage-IIb format, followed by a statistically powered randomised trial comparing the addition of DTI and iUS to the standard of care surgery. A total of 357 patients will be recruited for the RCT. The primary outcome is DFS, defined as the time to either 10-point deterioration in health-related quality of life scores from baseline, without subsequent reversal, progressive disease or death.
The trial was registered in the Integrated Research Application System (Ref: 264482) and approved by a UK research and ethics committee (Ref: 20/LO/0840). Results will be published in a peer-reviewed journal. Further dissemination to participants, patient groups and the wider medical community will use a range of approaches to maximise impact.
ISRCTN38834571.
手术仍然是治疗原发性胶质母细胞瘤的主要方法，随后是放疗和化疗。目前手术过程中使用的标准治疗方法包括术中图像引导和 5-氨基酮戊酸（5-ALA）。神经肿瘤外科医生还可以使用多种其他手术辅助方法。然而，在英国的实践中，这些方法的应用范围很广，且使用证据有限。本试验旨在研究在标准手术治疗（术中神经导航和 5-ALA）中添加弥散张量成像（DTI）和术中超声（iUS）是否会影响无恶化生存（DFS）。
这是一项两阶段、随机对照试验（RCT），包括基于 IDEAL（理念、开发、探索、评估和长期随访）阶段 IIb 格式的初始非随机队列研究，以及一项统计学上有说服力的随机试验，比较添加 DTI 和 iUS 与标准手术治疗的效果。总共将招募 357 名患者参加 RCT。主要结局是 DFS，定义为从基线开始健康相关生活质量评分恶化 10 分，没有随后的逆转、进行性疾病或死亡的时间。
该试验在综合研究应用系统（Ref：264482）中注册，并获得了英国研究和伦理委员会的批准（Ref：20/LO/0840）。结果将发表在同行评议的期刊上。进一步向参与者、患者群体和更广泛的医学界传播将采用多种方法以最大限度地提高影响力。
ISRCTN38834571。
