DAHANCA 24: Prognostic Value of 18F-FAZA in Head and Neck Squamous Cell Carcinoma (HNSCC)
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|ClinicalTrials.gov Identifier: NCT01017224|
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : May 14, 2012
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.
|Condition or disease||Intervention/treatment|
|Cancer of the Head and Neck||Other: 18F-FAZA|
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|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|
|Study Start Date :||November 2009|
|Primary Completion Date :||May 2012|
|Study Completion Date :||May 2012|
- Can 18F-FAZA can be used as a prognostic marker in HNSCC? [ Time Frame: 1, 5 years ]
- 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 ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01017224
|Department of Oncology, Aarhus University Hospital|
|Aarhus, Denmark, DK-8000|
|Principal Investigator:||Jens Overgaard, Prof., MD||Danish Head and Neck Cancer Group (DAHANCA)|