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Value of FLT-PET Before and During Radiotherapy in Head and Neck Tumors

Completed
Conditions
Head and Neck Neoplasms
Registration Number
NCT00163176
Lead Sponsor
Radboud University Medical Center
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Correlation of 18F-FLT-PET-signal changes before and during therapy with treatment outcome (clinical response and local tumor control)1 year
Secondary Outcome Measures
NameTimeMethod
Evaluation of the value of the functional information gained by 18F-FLT-PET regarding the definition of the planning target volume (PTV) for radiotherapy.2 months
Measurement of 18F-FLT-PET-signal changes during radiotherapy or radiochemotherapy.2 months

Trial Locations

Locations (1)

Radboud University Nijmegen, Department of Radiotherapy

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Nijmegen, Gelderland, Netherlands

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