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Completed

NCT Number: NCT01017224

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.

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Key information

Conditions

Cancer of the Head and Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oncology, Aarhus University Hospital

Aarhus, DK-8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-FAZA

Other

PET scan

Primary outcomes

  1. Can 18F-FAZA can be used as a prognostic marker in HNSCC?

    Time frame: 1, 5 years

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Danish Head and Neck Cancer Group

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 20, 2009
Registry last updated
May 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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