Clinical trial · Observational
A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis
NCT01077869CI-TRIAL-00004920terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor recruitment rate
Summary
Brief summary (as posted)
In this study, the feasibility of optical imaging and FDG-PET in the evaluation of radiation-induced mucositis will be evaluated.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Metastases | — | UNRESOLVED | — |
| Oropharynx Metastases | — | UNRESOLVED | — |
| Squamous Cell Carcinoma of the Oral Cavity | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopic examination | Procedure | — | UNRESOLVED |
| FDG-PET | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Feasibility of optical imaging in the evaluation of radiation-induced mucositis.
- timeFrame
- weekly assessment during 7 weeks
- measure
- Feasibility of FDG-PET in the evaluation of radiation-induced mucositis.
- timeFrame
- 2 weeks after radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.