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

NCT01077869 | Terminated

• 1 other identifier: 2009/621
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

oropharynx and lymph node metastases from an unknown primary tumor

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

endoscopic examination PROCEDURE

on a weekly basis during 7 weeks

FDG-PET PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Squamous cell carcinoma of the oral cavity, oropharynx and lymph node metastases from unknown primary tumor.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Links

• website University Hospital Ghent

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• wilfried De Neve, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 1, 2010
• Study Start: January 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 26, 2011

Record last verified: 2011-05

Locations

BE (1)