Ruijters V J, Snijders T J, van der Pol J A J, van de Giessen E M, Niers J M, Broen M P G, Anten M M, van Zanten S E M Veldhuijzen, Geurts M, Arens A I J, Henssen D J H A, Gijtenbeek J M, van der Meulen M, Sijben A E J, Ghariq E, Vos M J, Tim J, Bosma I B, Stormezand G N, Frederix G W J, Dankbaar J W, Robe P A, Verhoeff J J C, de Vos F Y F L, Lam M G E H, Ten Ham R M T, Tolboom N
Department of Neurology (VJR, TJS), Department of Epidemiology and Health Economics, Julius Centre (GWJF, RMTtH), Radiology (JWD), Neurosurgery (PAR), Medical Oncology (FYFLdV) and Nuclear Medicine (MGEHL, NT), UMC Utrecht, Utrecht, Netherlands.
Department of Neurology (MPGB, MMA) and Nuclear Medicine (JAJvdP), Maastricht UMC, Maastricht, Netherlands.
Trials. 2025 Jun 17;26(1):208. doi: 10.1186/s13063-025-08921-8.
During follow-up of glioblastoma patients after chemoradiation, expert teams often observe abnormalities on MRI with difficulty in distinguishing between tumor growth and pseudoprogression. Although advanced MRI techniques such as perfusion weighted imaging provide additional information, diagnostic uncertainty often remains, leading to incorrect or delayed diagnosis, and inappropriate treatment, such as unnecessary surgery. [F]Fluoro-ethyl-tyrosine positron emission tomography (FET PET) has good discriminating power for this setting. Still, this diagnostic tool is not used frequently in The Netherlands due to costs, logistics and uncertainty about clinical benefit. In the FET POPPING study, we aim to determine the added value of [F]FET PET for clinical management of glioblastoma patients.
A multicenter diagnostic randomized clinical trial will be performed, from August 2024 until December 2027. Adult patients (n=144) with isocitrate dehydrogenase (IDH)-wildtype glioblastoma will be included, who, at least ≥3 months after the concomitant phase of standard temozolomide-based chemoradiation, have new or increased contrast enhancement on MRI, causing doubt between tumor growth or pseudoprogression. In this trial, pseudoprogression will be used as an encompassing term that includes radionecrosis and other treatment-related changes after (chemo-)radiotherapy. Included patients will be randomized 1:1 in two arms. The investigational arm receives an additional [F]FET PET scan, and clinical management is based on the index MRI and [F]FET PET together. Clinical management of the control arm is based on the index MRI alone. Exact clinical management, as based on the available imaging, is chosen at the discretion of the local multidisciplinary board. The primary study endpoints are (a) the percentage of patients undergoing unnecessary interventions and (b) health-related quality of life after 12 weeks. Secondary endpoints include time-to-diagnosis, overall survival, and cost-effectiveness.
We hypothesize that the clinical management guided by an additional [F]FET PET scan leads to fewer unnecessary interventions, better health-related quality of life after 12 weeks and among others reduced net healthcare costs, compared with management based on MRI only.
The trial is registered on ClinicalTrials.gov on the 24th of June 2024, with registration number NCT06480721.
在胶质母细胞瘤患者放化疗后的随访期间，专家团队常常在磁共振成像（MRI）上观察到异常情况，难以区分肿瘤进展和假性进展。尽管诸如灌注加权成像等先进的MRI技术能提供更多信息，但诊断不确定性往往依然存在，导致诊断错误或延迟，以及治疗不当，比如进行不必要的手术。氟代乙基酪氨酸正电子发射断层扫描（FET PET）在此种情况下具有良好的鉴别能力。然而，由于成本、后勤保障以及临床获益的不确定性，这种诊断工具在荷兰并不常用。在FET POPPING研究中，我们旨在确定[F]FET PET对胶质母细胞瘤患者临床管理的附加价值。
将开展一项多中心诊断性随机临床试验，从2024年8月至2027年12月。纳入异柠檬酸脱氢酶（IDH）野生型胶质母细胞瘤的成年患者（n = 144），这些患者在基于替莫唑胺的同步放化疗阶段结束后至少≥3个月，MRI上出现新的或增强的对比增强，导致对肿瘤进展或假性进展存在疑问。在本试验中，假性进展将作为一个涵盖性术语，包括放射性坏死和放化疗后其他与治疗相关的变化。纳入的患者将按1:1随机分为两组。试验组接受额外的[F]FET PET扫描，临床管理基于索引MRI和[F]FET PET共同进行。对照组的临床管理仅基于索引MRI。具体的临床管理将由当地多学科委员会根据可用的影像自行决定。主要研究终点为：（a）接受不必要干预的患者百分比；（b）12周后的健康相关生活质量。次要终点包括诊断时间、总生存期和成本效益。
我们假设，与仅基于MRI的管理相比，额外的[F]FET PET扫描指导下的临床管理可减少不必要的干预，在12周后带来更好的健康相关生活质量，以及降低医疗净成本等。
该试验于2024年6月24日在ClinicalTrials.gov上注册，注册号为NCT06480721。
