FET-PET-Guided Management of Pseudoprogression in Glioblastoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVeerle Ruijters
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a glioblastoma, IDH-wildtype, World Health Organization (WHO) grade 4, according to WHO 2021 criteria.
Age ≥18 years
New or increased enhancement within the high-dose radiation field (defined as within the 80% isodose line) on follow-up MRI
Follow up MRI ≥3 months after the end of the standard-of-care temozolomide-based concomitant chemoradiation (60 Gy/30 fractions or 40 Gy/15 fractions). Of note, very early increase - within 3 months of last radiation - will not be grounds for inclusion because of the high rate of pseudoprogression and slightly lower diagnostic performance of FET-PET compared to the situation of increase beyond 3 months after last radiation. Patients with such very early increase may have subsequent further increase after 3 months post-radiation, causing (further) diagnostic doubt; these may be included at that later timepoint if they meet the other inclusion criteria.
Disqualifiers
Previous treatment for recurrence of disease
An enhanced lesion size of less than 1 cm on the index MRI. In the newest RANO PET criteria, it is advised to use FET-PET for increasing lesions only in cases with a minimum lesion size.
Life expectancy of less than 6 months, determined by the treating physician
Contra-indications for PET (claustrophobia, inability to lay still)
Trial design
Design model
Parallel
Treatments tested in this trial
Clinical management based on the index MRI and an additional [¹⁸F] FET PET scan
Other interventionPatients in the investigational arm will undergo the extra FET-PET scan, with use of the O-(2- ¹⁸F-fluoroethyl)-L-tyrosine (¹⁸F-FET) tracer. FET-PET scanning will be performed according to the joint European Association of Nuclear Medicine (EANM)/European Association of Neuro-Oncology (EANO)/Response Assessment in Neuro-oncology (RANO) guidelines. In most patients, a static scan (20-40 minutes post-injection) will performed. If the logistics of the research site allow for a dynamic scan (0-60 minutes post-injection), this will be performed. Interpretation will be done by an experienced nuclear medicine physician from the local center according to current European guidelines. Central review will be performed by a panel of nuclear medicine physicians from the study team. Clinical management is based on the index MRI and this additional \[¹⁸F\] FET PET scan.
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Clinical management is based on the index MRI and an additional [¹⁸F] FET-PET togetherExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
at six months2
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.
Time frame
at twelve weeks3
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.
Time frame
at twelve weeks4
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.
Time frame
at twelve weeksSecondary outcomes
1
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.
Time frame
at six months2
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.
Time frame
at six months3
Time-to-diagnosis
Defined as index MRI to eventual management, including watchful waiting
Time frame
During the study period (but expected within three months)4
Overall survival
Defined from index MRI until death (patients who are still alive at the end of the study will be censored)
Time frame
Through study completion (expected median of less than 1.5 year)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Veerle Ruijters
Lead sponsor
UMC Utrecht
Sponsor institution
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Curium PET France
Collaborator
Source ClinicalTrials.gov
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