Clinical trial · Interventional
Response Monitoring Trial in Patients With Suspected Recurrence of Glioblastoma
Randomized Metabolic Response Monitoring Trial in Patients With Suspected Recurrence of Glioblastoma FDOPA PET-CT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left HMRI
Summary
Brief summary (as posted)
It was previously shown that \[18F\]Fluorodopa (FDOPA) PET imaging results in intended management changes in 41% of brain tumor patients. However, its impact on patient outcome defined as survival, costs, and/or quality of life has not been demonstrated. Regulatory agencies require randomized trials to determine the impact of PET on patient management and outcome. In this study we hypothesize that the addition of FDOPA PET will improve patient outcome by more accurately identifying presence or absence of tumor recurrence than conventional imaging.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDOPA PET | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard diagnostics without PET
- description
- Standard of care brain imaging modalities, predominantly MRI
- type
- EXPERIMENTAL
- label
- FDOPA PET-CT
- description
- PET-CT with administration of FDOPA as an experimental radiopharmaceutical. This arm includes standard of care imaging plus FDOPA PET-CT
- interventionNames
- Drug: FDOPA PET
Primary outcomes (1)
- measure
- Diagnostic accuracy compared to standard diagnostics without PET
- timeFrame
- 5 years
- description
- Imaging findings will be validated by histopathology, clinical follow-up and/or repetitive imaging. If no histopathology within 3 months is available, clinical follow-up and imaging findings will be used for validation. If within 6 months of randomization no clinical progression nor progression on other imaging modalities is found, the patient will be rated as "no disease present at time of imaging".
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected first recurrence of a glioblastoma tumor by clinical measures and/or MRI * Age 18 and older Exclusion Criteria: * Breast feeding/ Pregnancy * Severe psychiatric illness * Primary diagnosis of a glioblastoma
References
Publications (0)
Data not yet available