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 F-DOPA PET/CT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
It was previously shown that 18F-DOPA 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 18F-DOPA PET will improve patient outcome by more accurately identifying presence or absence of tumor recurrence than conventional imaging.
Conditions
Conditions (2)
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 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDOPA PET/CT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard Diagnostics without PET
- type
- EXPERIMENTAL
- label
- Diagnostics with PET
- description
- All 18F-DOPA PET/CT studies will be interpreted qualitatively during a clinical readout session. Based on a previous study scans will be classified as positive if tumor regions defined on CT exhibited tracer uptake above the level of the contra-lateral caudate nucleus. Scans will be classified as negative if tumor 18F-FDOPA uptake is lower than that of the contra lateral caudate nucleus. Uptake at the level of the contra-lateral caudate will be considered equivocal for malignancy.
- interventionNames
- Radiation: FDOPA PET/CT
Primary outcomes (1)
- measure
- Diagnostic accuracy compared to standard diagnostics without PET
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected first recurrence of a glioblastoma tumor by clinical measures and/or MRI * Age 18-99 years Exclusion Criteria: * Breast feeding/ Pregnancy * Severe psychiatric illness * Primary diagnosis of a glioblastoma
References
Publications (0)
Data not yet available