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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01077869
Enrollment
10
Registered
2010-03-01
Start date
2010-01-31
Completion date
2011-05-31
Last updated
2011-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymph Metastases, Oropharynx Metastases, Squamous Cell Carcinoma of the Oral Cavity

Keywords

oropharynx and lymph node metastases from an unknown primary tumor

Brief summary

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

Interventions

on a weekly basis during 7 weeks

PROCEDUREFDG-PET

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

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026