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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Squamous Cell Carcinoma of the Oral Cavity, Oropharynx Metastases, Lymph Metastases

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Trial Information

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


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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Feasibility of optical imaging in the evaluation of radiation-induced mucositis.

Outcome Time Frame:

weekly assessment during 7 weeks

Safety Issue:

No

Principal Investigator

wilfried De Neve, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent

Authority:

Belgium: Institutional Review Board

Study ID:

2009/621

NCT ID:

NCT01077869

Start Date:

January 2010

Completion Date:

May 2011

Related Keywords:

  • Squamous Cell Carcinoma of the Oral Cavity
  • Oropharynx Metastases
  • Lymph Metastases
  • oropharynx and lymph node metastases from an unknown primary tumor
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Stomatitis
  • Mucositis

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