brain tumor Glioblastoma
Conditions
Interventions
The use of FET-PET (in addition to MRI) to differentiate between tumor growth 
pseudoprogression. 
 
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with a glioblastoma, IDH-wildtype, 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 (short- and long course). 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. - First moment of clinicoradiological uncertainty regarding the diagnosis (>=3 months after the end of chemoradiation): pseudoprogression or tumor recurrence. The determination of *uncertainty* is made by the treating physician, preferably in the multidisciplinary tumor board, based on available clinical and standard-of-care MRI-data, which generally includes perfusion-MRI. - Previous usage of bevacizumab as a symptom treatment is allowed. However, inclusion is only allowed at the first moment of clinical doubt between pseudoprogression and tumor recurrence, not at later timepoints.
Exclusion criteria
Exclusion criteria: - 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) - Women of childbearing potential without adequate contraception - Any other concomitant disease that may influence PET imaging or clinical outcomes of this study, this includes but is not limited to: cerebral inflammatory diseases and other cancers with brain- or leptomeningeal metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The percentage of patients undergoing unnecessary interventions: diagnostic biopsies, surgeries, medications. 2. Health related quality of life (EQ5D, EORTC-QLQ-BN20, iPCQ and iMCQ) at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| -Time-to-diagnosis (defined as index MRI to final treatment) -Overall survival (defined from index MRI) -Number of unnecessary treatment cycles -Cost-effectiveness in QALYs and ICERs -HRQOL (continuous measure): EQ5D, EORTC-QLQ-BN20, iPCQ and iMCQ at 6 weeks and 6 months | — |
Countries
Netherlands
Outcome results
None listed