[18F]FET PET-Guided management of pseudoprogression in glioblastoma (FET POPPING): the study protocol for a diagnostic randomized clinical trial

PMCID: PMC12175455

PMID: 40528226

DOI: 10.1186/s13063-025-08921-8

Journal: Trials

Publication Date: 2025-6-17

Authors: Ruijters VJ, Snijders TJ, van der Pol JA, van de Giessen EM, Niers JM, et al.

Key Points

• First comprehensive randomized trial investigating FET PET's utility in differentiating pseudoprogression from true tumor progression in glioblastoma
• Potential to reduce unnecessary interventions and improve patient management through advanced imaging techniques
• Aims to provide evidence-based guidance for clinical decision-making in challenging post-treatment glioblastoma imaging scenarios

Summary

The FET POPPING study is a multicenter diagnostic randomized clinical trial designed to evaluate the added value of [18F]Fluoro-ethyl-tyrosine positron emission tomography (FET PET) in managing patients with glioblastoma experiencing ambiguous MRI findings after chemoradiation. The study addresses a critical clinical challenge of distinguishing between tumor progression and pseudoprogression, which can lead to inappropriate treatment decisions.

The trial will randomize 144 adult patients with IDH-wildtype glioblastoma who have new or increased contrast enhancement on MRI at least 3 months after standard chemoradiation. Patients will be divided into two arms: one receiving additional FET PET imaging to guide clinical management, and a control group managed based on MRI alone. The primary endpoints include the percentage of unnecessary interventions and health-related quality of life at 12 weeks, with secondary endpoints of time-to-diagnosis, overall survival, and cost-effectiveness.