Squamous Cell Carcinoma of the Oral Cavity
Conditions
Interventions
Sponsors
Erasmus University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor; 2) = 18 years of age; 3) Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. 4) Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits, they are considered to be clinically insignificant; 5) The patient has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening; 6) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Exclusion criteria
Exclusion criteria: 1) Previous surgery, chemotherapy or radiotherapy to the oral cavity; 2) History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent. 3) Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential; 4) Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean tumor-to-background ratio (TBR) 2. Rate of adequate (i.e. >5mm clear) tumor resection margins | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sensitivity, specificity, positive and negative predictive values 2. Co-localization of FLI with immunohistochemistry on pathology slides 3. Percentage of extra tissue resection based on FLI-driven frozen sections 4. Operation time 5. FLI of lymph node metastases after neck dissection | — |
Contacts
Public ContactStijn Keereweer
Erasmus University Medical Center
Outcome results
None listed