Clinical trial · Interventional
Prognostic Evaluation of 18fmiso Pet-ct in Head and Neck Cancer
Prognostic Evaluation of Fluor 18 Labelled FLUROMISONIDAZOLE (18F-FMISO) Positon Emission Tomography-Computed Tomography (PET-CT) in Head and Neck Squamous Cell Carcinomas
- 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)
Head and neck cancer is the sixth most frequent cancer worldwide, excluding lymphomas and skin cancer. If 18FDG PET is considered today as a standard tool in patients with head and neck squamous cell carcinoma (HNSCC) not only for tumoral or nodal staging but also for assessment of distant metastases and synchronous second primary malignancies, hypoxia is one of the most important prognostic factors in radiotherapy of this type of tumors. The only gold standard method for direct determination of oxygen tension is based on using oxygen electrodes showing a good relation with clinical outcome but complex in its realisation. So, PET using 18F-FMISO has been described to be useful for the non invasive assessment of hypoxia in cancer. Especially in France, the use of this radiotracer is very limited and there is no standardised methodology to acquire and quantify 18F-FMISO signal. So there is a need for a rigorous evaluation of this PET tracer. In another way, it could be a very useful tool for evaluation of new therapies and modification of volumes in radiotherapy.
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 |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Positon Emission Tomography using 18F-FMISO | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TEP with 18F-FMISO
- description
- TEP with 18F-FMISO
- interventionNames
- Radiation: Positon Emission Tomography using 18F-FMISO
Primary outcomes (1)
- measure
- Correlation between a hypoxic volume determined by [18F]-FMISO PET-CT and a treatment response two years after radical treatment.
- timeFrame
- Inclusion (Day 0) and after two years
Secondary outcomes (2)
- measure
- Evaluate the potential role of a new biological tumour volume (BTV) taking account hypoxia for the delineation of volumes for radiotherapy treatment planning
- timeFrame
- Inclusion (Day 0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 * Patients presenting a squamous cell head and neck carcinoma proposed for a radical treatment consisting in conformational radiotherapy with or without chemotherapy or associated targeted therapy * Signed informed consent Exclusion Criteria: * Patients with distant metastases known before inclusion * Patients suffering of a second cancer or treated before by radiotherapy in the tumour site. * Pregnancy
References
Publications (2)
- RESULTHenriques de Figueiredo B, Zacharatou C, Galland-Girodet S, Benech J, De Clermont-Gallerande H, Lamare F, Hatt M, Digue L, De Mones del Pujol E, Fernandez P. Hypoxia imaging with [18F]-FMISO-PET for guided dose escalation with intensity-modulated radiotherapy in head-and-neck cancers. Strahlenther Onkol. 2015 Mar;191(3):217-24. doi: 10.1007/s00066-014-0752-8. Epub 2014 Sep 23. PMID 25245468
- RESULTHenriques de Figueiredo B, Merlin T, de Clermont-Gallerande H, Hatt M, Vimont D, Fernandez P, Lamare F. Potential of [18F]-fluoromisonidazole positron-emission tomography for radiotherapy planning in head and neck squamous cell carcinomas. Strahlenther Onkol. 2013 Dec;189(12):1015-9. doi: 10.1007/s00066-013-0454-7. Epub 2013 Nov 1. PMID 24173497