TerminatedNot Applicable

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

Stopped: poor recruitment rate

Belgium10 participantsStarted 2010-01

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: weekly assessment during 7 weeks

Feasibility of FDG-PET in the evaluation of radiation-induced mucositis.

Timeframe: 2 weeks after radiotherapy

Trial details

NCT IDNCT01077869

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2011-05

View on ClinicalTrials.gov More Squamous Cell Carcinoma of the Oral Cavity trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.