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

This study has been completed.
Information provided by (Responsible Party):
Radboud University Identifier:
First received: September 9, 2005
Last updated: December 15, 2011
Last verified: December 2011

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 Phase
Head and Neck Neoplasms
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Value of FLT-PET Before and During Radiotherapy in Head and Neck Tumors

Resource links provided by NLM:

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Correlation of 18F-FLT-PET-signal changes before and during therapy with treatment outcome (clinical response and local tumor control) [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Evaluation of the value of the functional information gained by 18F-FLT-PET regarding the definition of the planning target volume (PTV) for radiotherapy. [ Time Frame: 2 months ]
  • Measurement of 18F-FLT-PET-signal changes during radiotherapy or radiochemotherapy. [ Time Frame: 2 months ]

Enrollment: 50
Study Start Date: July 2005
Study Completion Date: December 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stage II-IV squamous cell carcinoma of the head and neck

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00163176

Radboud University Nijmegen, Department of Radiotherapy
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Principal Investigator: Johannes HA Kaanders, PhD Radboud University
  More Information

Responsible Party: Radboud University Identifier: NCT00163176     History of Changes
Other Study ID Numbers: 049
Study First Received: September 9, 2005
Last Updated: December 15, 2011

Keywords provided by Radboud University:
cell proliferation

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms processed this record on May 25, 2017