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

Conditions

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

  • Belgium
      • Ghent, Belgium
        • University Hospital Ghent

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
Feasibility of optical imaging in the evaluation of radiation-induced mucositis.
Time Frame: weekly assessment during 7 weeks
weekly assessment during 7 weeks
Feasibility of FDG-PET in the evaluation of radiation-induced mucositis.
Time Frame: 2 weeks after radiotherapy
2 weeks after radiotherapy

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

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

Keywords

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.

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