Clinical trial · Interventional
Hypoxia Analysis in Head and/or Neck Cancer
Predictive Methods Determining Tumour Hypoxia in Head and Neck Cancer Patients - a Prospective Project
NCT02414048CI-TRIAL-00022616unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The primary objective is the prospective determination of disease-specific and overall survival in head and neck cancer patients who have undergone surgery, correlated to non-invasive methods of measuring tumour hypoxia. The secondary objective is to define tumour hypoxia using non-invasive methodology.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pimonidazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Pimonidazole
- description
- All patients will receive Pimonidazole to demarcate hypoxia regions in the tumour
- interventionNames
- Drug: Pimonidazole
Primary outcomes (1)
- measure
- Disease-specific and overall survival correlated with tumour hypoxia
- timeFrame
- 5-years
- description
- Tumour hypoxia will be determined from the Pimonidazole staining and this will be correlated to disease-specific survival and overall survival. The study has been approved for 10 participants to be increased by the ethical committee to 100 once the study is going.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Malignancy in head and/or neck region only * Interdisciplinary Head and neck tumour board (USZ) confirmed inclusion in the project * For patients with reproductive potential (e.g. female participants who are surgically sterilised/hysterectomised or post-menopausal for longer than 2 years are not considered as beig of child bearing potential), a willingness to use adequate contraceptive measures to prevent pregnancy during the project. Exclusion Criteria: * Pregnant or breastfeeding * Suffers from claustrophobia * Known allergy to Pimonidazole * Participation in a study with an investigational drug within the 30 days preceding and during this project * Tumour size smaller than 1cm * Has symptomatic Chronic Obstructive Pulmonary Disease (COPD) * Patient refuses or is unable to give a written informed consent * Previous treatment for head and/or neck cancer * Inability to follow the procedures of the project e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
References
Publications (0)
Data not yet available
No reference posted for this study.