METHODS: This study is a nonrandomized, open-label, parallel-setting, prospective, monocentric clinical trial. The main aim of this study was to refine the diagnosis in patients with GBM with REP and to optimize subsequent radiotherapy planning. Glioblastoma patients who develop REP within approximately 6 weeks after surgery will undergo 11C-methionine positron emission tomography (PET/CT) examinations. Target volumes for radiotherapy are defined using both standard planning T1-weighted contrast-enhanced MRI and PET/CT. The primary outcome is progression-free survival defined using RANO criteria and compared to a historical cohort with REP treated without PET/CT optimization of radiotherapy.
CONCLUSIONS: PET is one of the most modern methods of molecular imaging. 11C-Methionine is an example of a radiolabelled (carbon 11) amino acid commonly used in the diagnosis of brain tumors and in the evaluation of response to treatment. Optimized radiotherapy may also have the potential to cover those regions with a high risk of subsequent progression, which would not be identified using standard-of-care MRI for radiotherapy planning. This is one of the first study focused on radiotherapy optimization for subgroup of patinets with REP.
BACKGROUND: NCT05608395, registered on 8.11.2022 in clinicaltrials.gov; EudraCT Number: 2020-000640-64, registered on 26.5.2020 in clinicaltrialsregister.eu. Protocol ID: MOU-2020-01, version 3.2, date 18.09.2020.
方法:这项研究是非随机的,开放标签,并行设置,prospective,单中心临床试验。这项研究的主要目的是完善REPGBM患者的诊断,并优化随后的放射治疗计划。在手术后大约6周内发生REP的胶质母细胞瘤患者将接受11C-甲硫氨酸正电子发射断层扫描(PET/CT)检查。使用标准计划T1加权对比增强MRI和PET/CT来定义放射治疗的目标体积。主要结果是使用RANO标准定义的无进展生存期,并与未经PET/CT优化放疗的REP治疗的历史队列进行比较。
结论:PET是最现代的分子成像方法之一。11C-甲硫氨酸是通常用于诊断脑肿瘤和评估对治疗的反应的放射性标记的(碳11)氨基酸的实例。优化的放疗也可能覆盖那些后续进展风险较高的区域。使用标准护理MRI进行放疗计划无法识别。这是第一项针对REP患者亚组的放射治疗优化研究之一。
背景:NCT05608395,于8.11.2022在clinicaltrials.gov中注册;EudraCT编号:2020-000640-64,于26.5.2020在clinicaltrialsregister中注册。欧盟。协议ID:MOU-2020-01,版本3.2,日期18.09.2020。