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

NCT01017224 | Completed

• 1 other identifier: DAHANCA 24
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer of the Head and Neck

Outcome Measures

Primary Outcomes (1)

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

  1, 5 years

Secondary Outcomes (1)

• 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

Interventions

18F-FAZA OTHER

PET scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

head and neck cancer patients

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Danish Head and Neck Cancer Group: collaborator

Study Sites (1)

Department of Oncology, Aarhus University Hospital

Aarhus, Aarhus, DK-8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

tissue

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

fluoroazomycin arabinoside

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Jens Overgaard, Prof., MD

  Danish Head and Neck Cancer Group (DAHANCA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 20, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 14, 2012

Record last verified: 2012-05

Locations

DK (1)