Clinical trial · Interventional
Evaluation of [18F]-FMISO for Non Operated Glioblastoma
Methodological Evaluation of Fluor 18 Labelled Fluoromisonidazole ([18F]-FMISO) Positon Emission Tomography-Computed Tomography (PET-CT) for Non Operated Glioblastoma
- 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)
Hypoxia is recognized to be an independent predictor of clinical outcome in oncology. PET using \[18F\]-FMISO has been described to be useful for the non invasive assessment of hypoxia in cancer. The use of this radiotracer for brain tumours is very limited and there is no standard to acquire and quantify \[18F\]-FMISO uptake. So there is a need for a methodological evaluation of this PET tracer The purpose of this research is to define optimal parameters for acquisition and data exploitation to quantify \[18F\]-FMISO uptake and so predict clinical outcome in glioblastomas. Low sensitivity to radiation of glioblastoma is partly caused by hypoxia. Hypoxia in tumours is not predicted by tumour size. Detecting and monitoring tissue oxygenation are of great interest to modify therapeutic strategies, including local dose escalation for radiotherapy or select chemotherapeutic agents with better impact in glioblastomas. PET with appropriate radiotracers, especially \[18F\]-FMISO, enables non-invasive assessment of hypoxia. \[18F\]-FMISO only accumulates in viable hypoxic cells. So, it has been demonstrated that PET using 18F-FMISO is suitable to localize and quantify hypoxia. But there isn't any optimal acquisition protocol or standardized images quantification treatment. Thus, the interpretation of \[18F\]-FMISO PET images and the predictive value of \[18F\]-FMISO SUV (Standardized Uptake Value) remain unclear explaining the need of methodological approaches.
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 | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F]-FMISO PET-CT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Procedure: 18F]-FMISO PET-CT
Primary outcomes (1)
- measure
- determine acquisition protocol and robust quantification parameters representative of tumour hypoxia using [18F]-FMISO PET-CT in glioblastomas
- timeFrame
- day 1
Secondary outcomes (3)
- measure
- prognostic value of [18F]-FMISO PET-CT in glioblastomas treated by conformational radiotherapy and/or chemotherapy
- timeFrame
- after one year
- measure
- Evaluate the potential role of a new biological tumour volume (BTV) taking into account hypoxia for the delineation of radiotherapy treatment planning when patients undergone this treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 * Patients with a malignant tumour glioblastomas proposed for a radical treatment consisting in conformational radiotherapy and/or chemotherapy * Signed informed consent Exclusion Criteria: * Patients who can't undergo radiotherapy or chemotherapy * Patients with distant metastases known before inclusion except renal cancer where patients with metastases can be included * Patients suffering of a second cancer or treated before by radiotherapy in the tumour site. * Pregnant and breast feeding women, women in age to procreate without contraception
References
Publications (1)
- RESULTHuchet A, Fernandez P, Allard M, Belkacemi Y, Maire JP, Trouette R, Eimer S, Tourdias T, Loiseau H. [Molecular imaging of tumor hypoxia]. Cancer Radiother. 2009 Dec;13(8):747-57. doi: 10.1016/j.canrad.2009.07.038. Epub 2009 Oct 23. French. PMID 19854090