Hypoxia and tumor cell proliferation are important mechanisms contributing to resistance to radiotherapy in human head and neck tumor cells. Currently, assessment of these two tumor characteristics is performed in biopsies using immunohistochemical staining and subsequent analysis. A promising non-invasive method of characterizing a tumor is the use of positron-emission tomography (PET). Specific tracers can be used to detect hypoxia and proliferative activity. 18F-misonidazole is a tracer for hypoxia and 18F-thymidine is a tracer for proliferation.

Patients suffering from head and neck cancer and who will undergo surgery will be included in this study.

One week before the surgery the patients will undergo a CT-scan and a PET-scan with either of the tracers. Shortly before the surgery they will be given immunohistochemically detectable marker substances enabling the characterization of the tumor samples gathered from the resection specimen. These markers are pimonidazole for detection of hypoxia and iododeoxyuridine for detection of tumor cell proliferation.

The data collected by PET-scan will be analysed and compared to the results acquired by immunohistochemistry.

Condition	Intervention	Phase
Head and Neck Neoplasms	Procedure: 18F-FLT and 18F-MISO-PET	Phase I

Further Study Details: 

Primary Outcomes: To validate 18F-MISO-PET for detection of tumor hypoxia and 18F-FLT-PET for detection of tumor cell proliferation by immunohistochemical assessment of hypoxia and proliferation in head and neck cancer resection specimen.
Secondary Outcomes: To assess if functional information obtained by 18F-MISO-PET and 18F-FLT-PET can improve the definition of target volume for radiotherapy treatment planning.
Expected Total Enrollment:  50

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Stage II-IV squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, planned for curative resection.

• Age >18 years. • Written informed consent.

Exclusion Criteria:

• Pregnancy. • Prior treatment for this tumor • Women breast feeding

Please refer to this study by ClinicalTrials.gov identifier  NCT00159978

Esther GC Troost, MD      +31-24-3614505    e.troost@rther.umcn.nl
Johannes HA Kaanders, PhD      +31-24-3614505    j.kaanders@rther.umcn.nl

Netherlands, Gelderland
      UMC St Radboud, Department of Radiotherapy, Nijmegen,  Gelderland,  6500 HB,  Netherlands; Recruiting

Study chairs or principal investigators

Johannes HA Kaanders, PhD,  Principal Investigator,  Radboud University   

Study ID Numbers:  100
Last Updated:  September 11, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00159978
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-09-13