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

December 15, 2011 updated by: Radboud University Medical Center

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboud University Nijmegen, Department of Radiotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stage II-IV squamous cell carcinoma of the head and neck

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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 months
Measurement of 18F-FLT-PET-signal changes during radiotherapy or radiochemotherapy.
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Johannes HA Kaanders, PhD, Radboud university medical center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

December 16, 2011

Last Update Submitted That Met QC Criteria

December 15, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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