Tumor cell proliferation and repopulation contribute to resistance to radiotherapy in head and neck cancer. Up to now, this characteristic is mostly assessed using biopsies acquired during inspection under general anaesthesia before treatment.

18F-FLT-PET (positron emission tomography) is a non-invasive imaging method showing areas of active proliferation. The aim of this study is to assess the value of the functional information gained by 18F-FLT-PET for radiotherapy planning and early tumor response assessment.

Prior to radiotherapy, a planning CT-scan and a 18F-FLT-PET scan are acquired. After approximately two weeks of radiotherapy a further PET scan is obtained.

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

Further Study Details: 

Primary Outcomes: a. Evaluation of the value of the functional information gained by 18F-FLT-PET regarding the definition of the planning target volume for radiotherapy.; b. Measurement of 18F-FLT-PET-signal changes during radiotherapy or radiochemotherapy.; c. Correlation of 18F-FLT-PET-signal changes before and during therapy with treatment outcome (clinical response and local tumor control)
Expected Total Enrollment:  50

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

Criteria

Inclusion Criteria:

1. Stage II - IV squamous cell carcinoma of the head-and-neck region, treated with radiotherapy or radiochemotherapy with curative intent.
2. 18 years or older
3. Informed consent

Exclusion Criteria:

1. Patients who have undergone surgery as primary tumor therapy.
2. Patients treated with palliative intent.
3. Pregnancy

Please refer to this study by ClinicalTrials.gov identifier  NCT00163176

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
      Radboud University Nijmegen, 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:  049
Last Updated:  September 12, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00163176
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-09-13