背景:胶质母细胞瘤(GBM)是最常见和侵袭性的原发性脑癌。GBM的治疗包括手术和随后的肿瘤治疗的组合,即,放射治疗,化疗,或他们的组合。如果术后肿瘤治疗涉及放疗,磁共振成像(MRI)用于放射治疗计划。不幸的是,在某些情况下,手术后几周观察到疾病的非常早期的恶化(进展)或复发(复发),这被称为快速早期进展(REP).放射治疗计划目前基于MRI,用于许多放射治疗设施中的目标体积定义。然而,REP患者可能受益于其他成像方式的靶向放疗.本临床试验的目的是评估11C-蛋氨酸在优化REP胶质母细胞瘤患者放疗中的实用性。
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。
BACKGROUND: Glioblastoma (GBM) is the most common and aggressive primary brain cancer. The treatment of GBM consists of a combination of surgery and subsequent oncological therapy, i.e., radiotherapy, chemotherapy, or their combination. If postoperative oncological therapy involves irradiation, magnetic resonance imaging (MRI) is used for radiotherapy treatment planning. Unfortunately, in some cases, a very early worsening (progression) or return (recurrence) of the disease is observed several weeks after the surgery and is called rapid early progression (REP). Radiotherapy planning is currently based on MRI for target volumes definitions in many radiotherapy facilities. However, patients with REP may benefit from targeting radiotherapy with other imaging modalities. The purpose of the presented clinical
trial is to evaluate the utility of 11C-methionine in optimizing radiotherapy for glioblastoma patients with REP.
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.