NCT06480721Not yet recruiting
FET-PET-Guided Management of Pseudoprogression in Glioblastoma
Source: ClinicalTrials.gov · Last updated 28 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 17 Jun 2024
- Start date
- Aug 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Veerle Ruijters
- Diseases
- Glioblastoma
- NCT number
- NCT06480721
What you commit to
- Study type: Interventional
- Planned participants: 144
- From Aug 2024 to the primary completion date, Dec 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment for recurrence of disease
- 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
Other
- 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
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Unknown status |
| UMC Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Radboud UMC Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Haaglanden MC Coordinator of this site? Confirm its status | The Hague | Netherlands | Unknown status |
| UMC Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.