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Abstract：
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-[18F]-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.
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.
摘要：
背景：成胶质细胞瘤是成年人中最常见的侵袭性原发性中枢神经系统癌症，其特征是均较差的生存率。尽管最大限度的安全切除和术后放疗同步和辅助替莫唑胺为基础的化疗，肿瘤不可避免地复发。使用O-（2-[18F]-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射治疗（RT）计划，区分治疗诱导的假性进展与肿瘤进展以及预后。
方法：胶质母细胞瘤的FET-PET（图）研究是一项前瞻性研究，多中心,非随机化，在澳大利亚的10个地点进行II期研究，将招募多达210名年龄≥18岁的新诊断成胶质细胞瘤的成年人。FET-PET将在最多三个时间点进行：（1）初次手术后和开始放化疗之前（FET-PET1）；（2）同步放化疗（FET-PET2）后4周；（3）在MRI上怀疑临床和/或放射学进展的14天内（在临床怀疑肿瘤复发时进行）（FET-PET3）。共同的主要结果是：（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实肿瘤进展方面的准确性和管理影响。次要结果是：（1）研究FET-PET参数之间的关系（包括动态摄取，肿瘤与背景的比率，代谢性肿瘤体积）和无进展生存期和总生存期；（2）在将放化疗前获得的FET-PET数据与其他预后标志物进行比较时，评估通过血清测定确定的血液和组织生物标志物的变化，通过MRI和FET-PET成像,观察FET-PET与MRI确定的化疗后疾病进展部位的关系;(3)评估将FET-PET纳入胶质母细胞瘤治疗以及评估治疗后假性进展或复发/真实进展的健康经济影响.探索性结果包括多模态成像的相关性，血液和肿瘤生物标志物分析与失败和生存模式。
背景：2020年11月20日的研究方案V.2.0已由领先的人类研究伦理委员会批准（AustinHealth，维多利亚）。其他临床场所将通过当地治理流程提供监督，包括获得适当参与者的知情同意。该研究将根据赫尔辛基宣言和良好临床实践的原则进行。FIG研究的结果（TROG18.06）将通过相关的科学和消费者论坛以及同行评审的出版物进行传播。
背景：ANZCTRACTRN12619001735145。
方法：胶质母细胞瘤的FET-PET（图）研究是一项前瞻性研究，多中心,非随机化，在澳大利亚的10个地点进行II期研究，将招募多达210名年龄≥18岁的新诊断成胶质细胞瘤的成年人。FET-PET将在最多三个时间点进行：（1）初次手术后和开始放化疗之前（FET-PET1）；（2）同步放化疗（FET-PET2）后4周；（3）在MRI上怀疑临床和/或放射学进展的14天内（在临床怀疑肿瘤复发时进行）（FET-PET3）。共同的主要结果是：（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实肿瘤进展方面的准确性和管理影响。次要结果是：（1）研究FET-PET参数之间的关系（包括动态摄取，肿瘤与背景的比率，代谢性肿瘤体积）和无进展生存期和总生存期；（2）在将放化疗前获得的FET-PET数据与其他预后标志物进行比较时，评估通过血清测定确定的血液和组织生物标志物的变化，通过MRI和FET-PET成像,观察FET-PET与MRI确定的化疗后疾病进展部位的关系;(3)评估将FET-PET纳入胶质母细胞瘤治疗以及评估治疗后假性进展或复发/真实进展的健康经济影响.探索性结果包括多模态成像的相关性，血液和肿瘤生物标志物分析与失败和生存模式。
背景：2020年11月20日的研究方案V.2.0已由领先的人类研究伦理委员会批准（AustinHealth，维多利亚）。其他临床场所将通过当地治理流程提供监督，包括获得适当参与者的知情同意。该研究将根据赫尔辛基宣言和良好临床实践的原则进行。FIG研究的结果（TROG18.06）将通过相关的科学和消费者论坛以及同行评审的出版物进行传播。
背景：ANZCTRACTRN12619001735145。
