A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis
Terminated
- Conditions
- Squamous Cell Carcinoma of the Oral CavityOropharynx MetastasesLymph Metastases
- Registration Number
- NCT01077869
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
In this study, the feasibility of optical imaging and FDG-PET in the evaluation of radiation-induced mucositis will be evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility of optical imaging in the evaluation of radiation-induced mucositis. weekly assessment during 7 weeks Feasibility of FDG-PET in the evaluation of radiation-induced mucositis. 2 weeks after radiotherapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Belgium