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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00163176
First received: September 9, 2005
Last updated: December 15, 2011
Last verified: December 2011
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Measurement of 18F-FLT-PET-signal changes during radiotherapy or radiochemotherapy. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00163176     History of Changes
Other Study ID Numbers: 049
Study First Received: September 9, 2005
Last Updated: December 15, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
cell proliferation
PET
radiotherapy

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

ClinicalTrials.gov processed this record on September 18, 2014