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
  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

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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Wilfried De Neve, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT01077869     History of Changes
Other Study ID Numbers: 2009/621
Study First Received: February 25, 2010
Last Updated: May 25, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
oropharynx and lymph node metastases from an unknown primary tumor

Additional relevant MeSH terms:
Neoplasm Metastasis
Carcinoma, Squamous Cell
Stomatitis
Neoplastic Processes
Neoplasms
Pathologic Processes
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 22, 2014