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NCT01077869 Clinical Trial

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

Squamous Cell Carcinoma of the Oral Cavity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01077869
Other study ID # 2009/621
Secondary ID
Status Terminated
Phase Phase 1
First received February 25, 2010
Last updated May 25, 2011
Start date January 2010
Est. completion date May 2011

Study information
Verified date May 2011
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• endoscopic examination
on a weekly basis during 7 weeks
• FDG-PET
once pre-radiotherapy and once 2 weeks after initiation of radiotherapy

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility of optical imaging in the evaluation of radiation-induced mucositis. weekly assessment during 7 weeks No
Primary Feasibility of FDG-PET in the evaluation of radiation-induced mucositis. 2 weeks after radiotherapy No
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Active, not recruiting NCT03370276 - Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma Phase 1/Phase 2
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