A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis
May 25, 2011 updated by: University Hospital, Ghent
In this study, the feasibility of optical imaging and FDG-PET in the evaluation of radiation-induced mucositis will be evaluated.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
10
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
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Ghent, Belgium
- University Hospital Ghent
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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
Squamous cell carcinoma of the oral cavity, oropharynx and lymph node metastases from unknown primary tumor.
Description
Inclusion Criteria:
- Non-operated histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx (except the posterior wall) and lymph node metastases from the unknown primary tumor (CUP)
- Stage T1-4; Tx N+ for the CUP
- Multidisciplinary Group of Head and Neck Tumors at Ghent University Hospital decision of radical radiotherapy (±concurrent chemotherapy)
- Informed consent obtained, signed and dated before specific protocol procedures.
Exclusion Criteria:
- Age < 18 years
- Pregnant or lactating women
- Active infection or fistula in the oral/oropharyngeal mucosa
- Previous cancer of the oral cavity and the oropharynx
- Prior head-and-neck radiotherapy
- Expectation of non-compliance with the study protocol
- Known allergy for topical anesthetics (Xylocaïne)
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 |
|---|---|
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Feasibility of optical imaging in the evaluation of radiation-induced mucositis.
Time Frame: weekly assessment during 7 weeks
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weekly assessment during 7 weeks
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Feasibility of FDG-PET in the evaluation of radiation-induced mucositis.
Time Frame: 2 weeks after radiotherapy
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2 weeks after radiotherapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
January 1, 2010
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
February 25, 2010
First Submitted That Met QC Criteria
February 26, 2010
First Posted (Estimate)
March 1, 2010
Study Record Updates
Last Update Posted (Estimate)
May 26, 2011
Last Update Submitted That Met QC Criteria
May 25, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009/621
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.