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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Squamous Cell Carcinoma of the Oral Cavity Oropharynx Metastases Lymph Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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endoscopic examination

on a weekly basis during 7 weeks

Intervention Type PROCEDURE

FDG-PET

once pre-radiotherapy and once 2 weeks after initiation of radiotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No