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:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01077869
First received: February 25, 2010
Last updated: May 25, 2011
Last verified: May 2011

February 25, 2010
May 25, 2011
January 2010
May 2011   (final data collection date for primary outcome measure)
  • Feasibility of optical imaging in the evaluation of radiation-induced mucositis. [ Time Frame: weekly assessment during 7 weeks ] [ Designated as safety issue: No ]
  • Feasibility of FDG-PET in the evaluation of radiation-induced mucositis. [ Time Frame: 2 weeks after radiotherapy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01077869 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis
A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Squamous Cell Carcinoma of the Oral Cavity
  • Oropharynx Metastases
  • Lymph Metastases
  • Procedure: endoscopic examination
    on a weekly basis during 7 weeks
  • Procedure: FDG-PET
    once pre-radiotherapy and once 2 weeks after initiation of radiotherapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
May 2011
May 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01077869
2009/621
No
Wilfried De Neve, MD, PhD, University Hospital Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: wilfried De Neve, MD, PhD University Hospital, Ghent
University Hospital, Ghent
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP