Clinical trial · Observational
Impact of [11C]-Methionine PET/MRI for Individual Tailoring Postoperative Radiochemotherapy for Glioblastoma Multiforme
Observational Study of Impact of [11C]-Methionine PET/MRI as a Tool for Individual Tailoring Postoperative Radiochemotherapy for Patients With Glioblastoma Multiforme
- 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)
Local recurrence is a major problem of clinical treatment of glioblastoma multiforme (GBM). Today a very sensitive imaging method to detect glioblastoma is \[11C\]MET Positron emission tomography (PET), where in some patients also tumour manifestations can be detected that are not visible in MRI investigations. The aim of the study is to investigate the association of high \[11C\]MET tracer uptake before postoperative radiochemotherapy and concurrent temozolomide (TMZ) with time to recurrence in patients with glioblastoma multiforme. Also site of recurrence will be correlated with the \[11C\]MET imaging before and early during radiochemotherapy. All imaging information will be included in treatment planning or treatment decisions. The study provides a basis for later radiation dose escalation trials on the base of \[11C\]MET imaging.
Conditions
Conditions (1)
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 Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiochemotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Radiochemotherapy
- description
- glioblastoma patients with indication to radiochemotherapy
- interventionNames
- Radiation: Radiochemotherapy
Primary outcomes (1)
- measure
- Time to recurrence as function of [11C]MET uptake before postoperative radiochemotherapy
- timeFrame
- participants will be followed until tumour recurrence, an expected average of 7 months
Secondary outcomes (1)
- measure
- overall survival
- timeFrame
- expected average 15 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed newly diagnosed glioblastoma multiforme * macroscopic total tumour resection or biopsy * indication for combined radiochemotherapy with temozolomide * patients are allowed to take part in other clinical trials at the same time * beginning of radiochemotherapy no later than 7 weeks after surgery * Karnofsky Performance Score ≥ 60, ECOG ≤2 * women with childbearing potential, (and men) adequate contraception * ability of subject to understand character and individual consequences of the clinical trial * written informed consent Exclusion Criteria: * previous radiotherapy of the brain or chemotherapy with TMZ other than during the radiochemotherapy * time interval of \> 7 weeks after surgery and beginning of radiochemotherapy * patients who are not suitable for radiochemotherapy * known other malignant disease that impacts prognosis of the patient and/or is likely to require treatment interfering with study therapy * pregnant or lactating women * patients with non-MRI compatible metal implants, pacemaker or non-MRI compatible external automatic defibrillators, insulin pumps, neurostimulators, cochlear implants * Claustrophobic patients * refusal of the patients to take part in the study
References
Publications (0)
Data not yet available