DAHANCA 24: Prognostic Value of 18F-FAZA in Head and Neck Squamous Cell Carcinoma (HNSCC)

Study Overview
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Brief Summary
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Solid tumours contain varying degrees of hypoxia. Studies show hypoxia to be associated with poor local control and survival, as hypoxia is a cause of resistance to radio- and chemotherapy and the development of a more aggressive tumour. Previous attempts to measure hypoxia have been biased because the techniques have been invasive, not repeatable or difficult to apply on a routine basis. There is great interest in trying to measure hypoxia in tumours as this could lead to individualized hypoxia-modifying therapy and prediction of treatment response. Additionally the investigators' knowledge of change in hypoxia over time is limited, but of great interest as individualised treatment, such as intensity-modulated radiation therapy (IMRT) is emerging. 18F-FAZA, appears promising. It is a nitroimidazole, which gets trapped in hypoxic cells and can be detected by a positron emission therapy (PET) scan. Compared to other nitroimidazoles, 18F-FAZA has superior biokinetics and thereby is believed to provide a faster and clearer image of hypoxia. The investigators' hypothesis is that 18F-FAZA can be used as a prognostic marker in HNSCC.

Official Title
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DAHANCA 24: Prognostic Value of 18F-FAZA Positron Emission Tomography After Primary Curative Radiotherapy for Squamous Cell Carcinoma of the Head and Neck

Conditions
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Cancer of the Head and Neck

Intervention / Treatment
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* Other: 18F-FAZA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological proven squamous cell carcinoma of the pharynx, larynx, oropharynx and hypopharynx Curative intent and no prior treatment Age >= 18 years stage T1-4 N0-N3 M0. Informed consent according to local guidelines and national law The patient is able (psychological, sociological, geographical and physical) to carry through the treatment and follow-up Fertile women must use contraceptive devices (IUD or oral contraceptives) Exclusion Criteria: No serious concurrent medical disease No metastasis No prior disease that can affect the treatment, evaluation or outcome of current disease No pregnant or breastfeeding woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: 18F-FAZA|PET scan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Can 18F-FAZA can be used as a prognostic marker in HNSCC? |  | 1, 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the changes in hypoxia in solid tumours as assessed by 18F-FAZA PET during radiotherapy |  | Patients will be scanned prior to treatment, every 2 weeks during their treatment and once following radiation |