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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01017224
Enrollment
40
Registered
2009-11-20
Start date
2009-11-30
Completion date
2012-05-31
Last updated
2012-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of the Head and Neck

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.

Interventions

PET scan

Sponsors

Danish Head and Neck Cancer Group
CollaboratorNETWORK
University of Aarhus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Can 18F-FAZA can be used as a prognostic marker in HNSCC?1, 5 years

Secondary

MeasureTime frame
Determine the changes in hypoxia in solid tumours as assessed by 18F-FAZA PET during radiotherapyPatients will be scanned prior to treatment, every 2 weeks during their treatment and once following radiation

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026