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

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.
 
ClinicalTrials.gov Identifier: NCT00163176
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : December 16, 2011
Sponsor:
Information provided by (Responsible Party):
Radboud University

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.


Condition or disease
Head and Neck Neoplasms

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Value of FLT-PET Before and During Radiotherapy in Head and Neck Tumors
Study Start Date : July 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Measurement of 18F-FLT-PET-signal changes during radiotherapy or radiochemotherapy. [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
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Netherlands
Radboud University Nijmegen, Department of Radiotherapy
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Johannes HA Kaanders, PhD Radboud University
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00163176    
Other Study ID Numbers: 049
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: December 2011
Keywords provided by Radboud University:
cell proliferation
PET
radiotherapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms