Radiation Oncology, Liverpool Hospital, Liverpool, New South Wales, Australia
South West Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
BMJ Open. 2023 Aug 4;13(8):e071327. doi: 10.1136/bmjopen-2022-071327.
Glioblastoma is the most common aggressive primary central nervous system cancer in adults characterised by uniformly poor survival. Despite maximal safe resection and postoperative radiotherapy with concurrent and adjuvant temozolomide-based chemotherapy, tumours inevitably recur. Imaging with O-(2-[F]-fluoroethyl)-L-tyrosine (FET) positron emission tomography (PET) has the potential to impact adjuvant radiotherapy (RT) planning, distinguish between treatment-induced pseudoprogression versus tumour progression as well as prognostication.
The FET-PET in Glioblastoma (FIG) study is a prospective, multicentre, non-randomised, phase II study across 10 Australian sites and will enrol up to 210 adults aged ≥18 years with newly diagnosed glioblastoma. FET-PET will be performed at up to three time points: (1) following initial surgery and prior to commencement of chemoradiation (FET-PET1); (2) 4 weeks following concurrent chemoradiation (FET-PET2); and (3) within 14 days of suspected clinical and/or radiological progression on MRI (performed at the time of clinical suspicion of tumour recurrence) (FET-PET3). The co-primary outcomes are: (1) to investigate how FET-PET versus standard MRI impacts RT volume delineation and (2) to determine the accuracy and management impact of FET-PET in distinguishing pseudoprogression from true tumour progression. The secondary outcomes are: (1) to investigate the relationships between FET-PET parameters (including dynamic uptake, tumour to background ratio, metabolic tumour volume) and progression-free survival and overall survival; (2) to assess the change in blood and tissue biomarkers determined by serum assay when comparing FET-PET data acquired prior to chemoradiation with other prognostic markers, looking at the relationships of FET-PET versus MRI-determined site/s of progressive disease post chemotherapy treatment with MRI and FET-PET imaging; and (3) to estimate the health economic impact of incorporating FET-PET into glioblastoma management and in the assessment of post-treatment pseudoprogression or recurrence/true progression. Exploratory outcomes include the correlation of multimodal imaging, blood and tumour biomarker analyses with patterns of failure and survival.
The study protocol V.2.0 dated 20 November 2020 has been approved by a lead Human Research Ethics Committee (Austin Health, Victoria). Other clinical sites will provide oversight through local governance processes, including obtaining informed consent from suitable participants. The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Results of the FIG study (TROG 18.06) will be disseminated via relevant scientific and consumer forums and peer-reviewed publications.
ANZCTR ACTRN12619001735145.
胶质母细胞瘤是成人中最常见的侵袭性原发性中枢神经系统癌症，其总体生存率均较差。尽管进行了最大程度的安全切除以及术后放化疗联合替莫唑胺化疗，但肿瘤仍不可避免地复发。O-(2-[F]-氟乙基)-L-酪氨酸（FET）正电子发射断层扫描（PET）成像有可能影响辅助放疗（RT）计划，区分治疗诱导的假性进展与肿瘤进展，并进行预后评估。
FET-PET 在胶质母细胞瘤（FIG）研究中是一项前瞻性、多中心、非随机、二期研究，在澳大利亚的 10 个地点进行，最多纳入 210 名年龄≥18 岁的新诊断为胶质母细胞瘤的成年人。FET-PET 将在最多三个时间点进行：（1）初始手术后且在放化疗开始前（FET-PET1）；（2）同期放化疗后 4 周（FET-PET2）；（3）在 MRI 上疑似临床和/或放射学进展时的 14 天内（在怀疑肿瘤复发时进行）（FET-PET3）。主要结局是：（1）研究 FET-PET 与标准 MRI 如何影响 RT 体积描绘；（2）确定 FET-PET 在区分假性进展与真性肿瘤进展方面的准确性和管理影响。次要结局是：（1）研究 FET-PET 参数（包括动态摄取、肿瘤与背景比、代谢肿瘤体积）与无进展生存期和总生存期之间的关系；（2）通过比较放化疗前的 FET-PET 数据与其他预后标志物，评估由血清测定确定的血液和组织生物标志物的变化，研究 FET-PET 与化疗后治疗后 MRI 和 FET-PET 成像确定的疾病进展部位/区域之间的关系；（3）评估将 FET-PET 纳入胶质母细胞瘤管理以及评估治疗后假性进展或复发/真性进展的健康经济影响。探索性结局包括多模态成像、血液和肿瘤生物标志物分析与失败模式和生存的相关性。
2020 年 11 月 20 日修订的研究方案 V.2.0 已获得主要人类研究伦理委员会（澳大利亚维多利亚州的奥斯汀健康中心）的批准。其他临床站点将通过当地治理程序提供监督，包括从合适的参与者处获得知情同意。该研究将符合《赫尔辛基宣言》和良好临床实践的原则进行。FIG 研究（TROG 18.06）的结果将通过相关的科学和消费者论坛以及同行评审出版物进行传播。
ANZCTR ACTRN12619001735145。
