Oral Squamous Cell Carcinoma Mouth cancer
Conditions
Interventions
Patients suffering from oral squamous cell carcinoma will, after written informed consent, be randomly assigned to either the control or the intervention group. Patients enrolled in the intervention g
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Cytology and/or histology-confirmed diagnosis of oral squamous cell carcinoma and scheduled to undergo surgical removal as decided by the multidisciplinary head and neck tumor board of the UMCG.Age = 18 years.Written informed consent.
Exclusion criteria
Exclusion criteria: Medical or psychiatric conditions that compromise the patient’s ability to give informed consent as determined by study team.Concurrent uncontrolled medical conditions as judged by the primary physician of the patient.Participated in a clinical trial in which an investigational drug was administrated within 30 days prior to the dose of cetuximab-800CW.History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure with significant risk of cetuximab not being tolerated, as determined by the treating physician.Inadequately controlled hypertension – as defined by the treating physician – with or without current antihypertensive medications.History of allergy or infusion reactions to cetuximab or other monoclonal antibody therapies.Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. Moreover, the need to be willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter. Woman of childbearing potential are premenopausal women with intact reproductive organs and women less than two years after menopause.Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.Life expectancy < 12 weeks, as judged by the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare surgical outcome in terms of margin status between the intervention cohort and the standard of care cohort a. Assessing the rate of margin conversion, i.e. how often fluorescence imaging leads to intraoperative reresection resulting in tumor free margins, comparing tumor margin status without and after study related interventions. b. The effect on adjuvant treatment in patients where the margin was adjusted after identifying an inadequate margin by fluorescence imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determining diagnostic parameters (including predictive values, sensitivity, specificity, type I & II errors) of fluorescence imaging for identifying inadequate tumor margins.Implementation of an intraoperative feedback workflow between the pathology department and surgery team on the margin assessment by FI.Retrospective comparison between standard fluorescence imaging devices and a novel technique using dual aperture fluorescence imaging as an exploratory objective. | — |
Countries
Netherlands
Contacts
Public ContactM.J.H. Witjes
Universitair Medisch Centrum Groningen
Outcome results
None listed