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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00163176
First Posted: September 13, 2005
Last Update Posted: December 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Radboud University
  Purpose

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)
  Eligibility

Information from the National Library of Medicine

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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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163176


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

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00163176     History of Changes
Other Study ID Numbers: 049
First Submitted: September 9, 2005
First Posted: September 13, 2005
Last Update Posted: December 16, 2011
Last Verified: December 2011

Keywords provided by Radboud University:
cell proliferation
PET
radiotherapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms