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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

This study has been terminated.
(poor recruitment rate)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01077869
First Posted: March 1, 2010
Last Update Posted: May 26, 2011
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.
Information provided by:
University Hospital, Ghent
  Purpose
In this study, the feasibility of optical imaging and FDG-PET in the evaluation of radiation-induced mucositis will be evaluated.

Condition Intervention Phase
Squamous Cell Carcinoma of the Oral Cavity Oropharynx Metastases Lymph Metastases Procedure: endoscopic examination Procedure: FDG-PET Phase 1

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

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

Estimated Enrollment: 10
Study Start Date: January 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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): NCT01077869


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

Additional Information:
Responsible Party: Wilfried De Neve, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT01077869     History of Changes
Other Study ID Numbers: 2009/621
First Submitted: February 25, 2010
First Posted: March 1, 2010
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:
Carcinoma, Squamous Cell
Neoplasm Metastasis
Neoplasms, Second Primary
Mucositis
Stomatitis
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplastic Processes
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases