DAHANCA 24: Prognostic Value of 18F-FAZA in Head and Neck Squamous Cell Carcinoma (HNSCC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||May 2012|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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)|