FET-PET-Guided Management of Pseudoprogression in Glioblastoma
NCT Number: NCT06480721
Acronym: FET-POPPING
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Glioblastoma|Radionecrosis of Brain
Interventions: OTHER: Clinical management based on the index MRI and an additional [¹⁸F] FET PET scan
Sponsor: Veerle Ruijters
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development|Curium PET France
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 144
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2027-12
Locations: Amsterdam UMC, Amsterdam, Netherlands|Haaglanden MC, Den Haag, Netherlands|Medisch Spectrum Twente, Enschede, Netherlands|UMC Groningen, Groningen, Netherlands|Maastricht UMC, Maastricht, Netherlands|Radboud UMC, Nijmegen, Netherlands|Erasmus MC, Rotterdam, Netherlands|UMC Utrecht, Utrecht, 3508 GA, Netherlands

Summary:
The goal of this diagnostic randomised clinical trial is to determine, in glioblastoma patients with diagnostic uncertainty between pseudoprogression and tumor progression on follow-up MRI after chemoradiation, the added value of a direct \[¹⁸F\] FET-PET scan for clinical management.

The main questions it aims to answer are:

* Does the clinical management guided by an additional FET-PET scan leads to fewer unnecessary interventions, compared with management based on MRI only?
* Does the clinical management guided by an additional FET-PET scan leads to better health-related quality of life after 12 weeks, compared with management based on MRI only?
* Does the clinical management guided by an additional FET-PET scan leads to reduced net healthcare costs, compared with management based on MRI only?

Researchers will compare the investigational arm, where clinical management is based on the index MRI scan and an additional FET-PET scan, with the control arm, where clinical management is based solely on the index MRI scan, to investigate the added value of the FET PET scan for clinical management.

Participants in the investigational arm will undergo the FET PET scan. All participants will complete health-related quality of life questionnaires at four different timepoints.

Primary Outcome Measures: Composite score of proportion (0-100%) of patients undergoing unnecessary interventions., Determination of 'unnecessary interventions' will be done retrospectively, by the researchers and the treating physician.

An 'unnecessary intervention' is defined as:

* Biopsy or debulking for diagnostic uncertainty and/or with pseudoprogression as the final pathological diagnosis
* The administration of one or more cycles of (temozolomide) chemotherapy as continued treatment for presumed pseudoprogression, in cases with a final diagnosis of tumor progression
* The administration of one or more doses of bevacizumab for presumed pseudoprogression, in cases with a final diagnosis of tumor progression, at six months|Health-related quality of life: general, This will be reported by the questionnaire EQ5D. The EQ5D is a generic utility questionnaire which allows for comparison of quality of life between indications, and is considered the golden standard by the Dutch National Heath Care Institute. Both the total score of the questionnaire is used as the individual scores to analyse individual patients' changes over time., at twelve weeks|Health-related quality of life: brain tumor specific, This will be reported by the questionnaire European Organization for Research and Treatment of Cancer Quality of Life Brain Cancer Module (EORTC-QLQ-BN20). The EORTC-QLQ-BN20 is a brain tumor specific questionnaire and is a reliable tool to capture changes in specific health domains for this population. Both the total score of the questionnaire is used as the individual scores to analyse individual patients' changes over time., at twelve weeks|Health-related quality of life: productivity, This will be reported by the questionnaire iMTA Productivity Cost Questionnaire (iPCQ). The iPCQ questionnaire measures productivity losses and is applicable to national and international studies.

Both the total score of the questionnaire is used as the individual scores to analyse individual patients' changes over time., at twelve weeks|Health-related quality of life: medical consumption, This will be reported by the questionnaire iMTA Medical Consumption Questionnaire (iMCQ). The iMCQ questionnaire is an instrument for measuring medical consumption. Both the total score of the questionnaire is used as the individual scores to analyse individual patients' changes over time., at twelve weeks
Secondary Outcome Measures: Cost-effectiveness, Expressed in Quality Adjusted Life Years (QALY). The results of the cost utility analysis will be combined with observed and extrapolated uptake to estimate the budget impact over several relevant time horizons., at six months|Cost-effectiveness, Expressed in Incremental Cost Effectiveness Ratio's (ICERs). The results of the cost utility analysis will be combined with observed and extrapolated uptake to estimate the budget impact over several relevant time horizons., at six months|Time-to-diagnosis, Defined as index MRI to eventual management, including watchful waiting, During the study period (but expected within three months)|Overall survival, Defined from index MRI until death (patients who are still alive at the end of the study will be censored), Through study completion (expected median of less than 1.5 year)|Number of unnecessary treatment cycles, Chemotherapy, at six months|Health-related quality of life: general, This will be reported by the questionnaire EQ5D. The EQ5D is a generic utility questionnaire which allows for comparison of quality of life between indications, and is considered the golden standard by the Dutch National Heath Care Institute. Both the total score of the questionnaire is used as the individual scores to analyse individual patients' changes over time., at six weeks and six months|Health-related quality of life: brain tumor specific, This will be reported by the questionnaire European Organization for Research and Treatment of Cancer Quality of Life Brain Cancer Module (EORTC-QLQ-BN20). The EORTC-QLQ-BN20 is a brain tumor specific questionnaire and is a reliable tool to capture changes in specific health domains for this population. Both the total score of the questionnaire is used as the individual scores to analyse individual patients' changes over time., at six weeks and six months|Health-related quality of life: productivity, This will be reported by the questionnaire iMTA Productivity Cost Questionnaire (iPCQ). The iPCQ questionnaire measures productivity losses and is applicable to national and international studies.

Both the total score of the questionnaire is used as the individual scores to analyse individual patients' changes over time., at six weeks and six months|Health-related quality of life: medical consumption, This will be reported by the questionnaire iMTA Medical Consumption Questionnaire (iMCQ). The iMCQ questionnaire is an instrument for measuring medical consumption. Both the total score of the questionnaire is used as the individual scores to analyse individual patients' changes over time., at six weeks and six months