FET-PET-Guided management of pseudoprogression in Glioblastoma
- Conditions
- brain tumorGlioblastoma10029211
- Registration Number
- NL-OMON56794
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 144
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. The percentage of patients undergoing unnecessary interventions: diagnostic<br /><br>biopsies, surgeries, medications.<br /><br>2. Health related quality of life (EQ5D, EORTC-QLQ-BN20, iPCQ and iMCQ) at 12<br /><br>weeks </p><br>
- Secondary Outcome Measures
Name Time Method <p>-Time-to-diagnosis (defined as index MRI to final<br /><br>treatment)<br /><br>-Overall survival (defined from index<br /><br>MRI)<br /><br>-Number of unnecessary treatment<br /><br>cycles<br /><br>-Cost-effectiveness in QALYs and ICERs<br /><br>-HRQOL (continuous measure): EQ5D,<br /><br>EORTC-QLQ-BN20, iPCQ and iMCQ at 6 weeks and 6<br /><br>months </p><br>