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

Ghent University Hospital (UZ)

Status: Terminated

Conditions: Squamous Cell Carcinoma of the Oral Cavity; Oropharynx Metastases; Lymph Metastases

Treatments: Procedure: FDG-PET; Procedure: endoscopic examination

Study type: Observational

Funder types: Other

Identifiers

NCT01077869

2009/621

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)