DAHANCA 24: Prognostic Value of 18F-FAZA in Head and Neck Squamous Cell Carcinoma (HNSCC)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||DAHANCA 24: Prognostic Value of 18F-FAZA Positron Emission Tomography After Primary Curative Radiotherapy for Squamous Cell Carcinoma of the Head and Neck|
- Can 18F-FAZA can be used as a prognostic marker in HNSCC? [ Time Frame: 1, 5 years ] [ Designated as safety issue: No ]
- Determine the changes in hypoxia in solid tumours as assessed by 18F-FAZA PET during radiotherapy [ Time Frame: Patients will be scanned prior to treatment, every 2 weeks during their treatment and once following radiation ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||November 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017224
|Department of Oncology, Aarhus University Hospital|
|Aarhus, Denmark, DK-8000|
|Principal Investigator:||Jens Overgaard, Prof., MD||Danish Head and Neck Cancer Group (DAHANCA)|