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A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis

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ClinicalTrials.gov Identifier: NCT01077869
Recruitment Status : Terminated (poor recruitment rate)
First Posted : March 1, 2010
Last Update Posted : May 26, 2011
Sponsor:
Information provided by:
University Hospital, Ghent

Study Description
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Brief Summary:
In this study, the feasibility of optical imaging and FDG-PET in the evaluation of radiation-induced mucositis will be evaluated.

Condition or disease Intervention/treatment
Squamous Cell Carcinoma of the Oral Cavity Oropharynx Metastases Lymph Metastases Procedure: endoscopic examination Procedure: FDG-PET

Study Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis
Study Start Date : January 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

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Groups and Cohorts
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Intervention Details:
  • Procedure: endoscopic examination
    on a weekly basis during 7 weeks
  • Procedure: FDG-PET
    once pre-radiotherapy and once 2 weeks after initiation of radiotherapy

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

Eligibility Criteria
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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
Squamous cell carcinoma of the oral cavity, oropharynx and lymph node metastases from unknown primary tumor.
Criteria

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)
Contacts and Locations
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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): NCT01077869


Locations
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Belgium
University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: wilfried De Neve, MD, PhD University Hospital, Ghent
More Information
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Additional Information:

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Responsible Party: Wilfried De Neve, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT01077869    
Other Study ID Numbers: 2009/621
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: May 26, 2011
Last Verified: May 2011
Keywords provided by University Hospital, Ghent:
oropharynx and lymph node metastases from an unknown primary tumor
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Mucositis
Stomatitis
Neoplasms
Neoplastic Processes
 Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases