CETUXIMAB for Oral squamous cell carcinoma

Inclusion criteria

• {"criterion_text":"- 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\n- Age ≥ 18 years\n- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- Medical or psychiatric conditions that compromise the patient’s ability to give informed consent as determined by study team\n- Concurrent uncontrolled medical conditions as judged by the primary physician of the patient\n- Participated in a clinical trial in which an investigational drug was administrated within 30 days prior to the dose of cetuximab-800CW\n- History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure with significant risk of cetuximab not being tolerated, as determined by the treating physician\n- Inadequately controlled hypertension – as defined by the treating physician – with or without current antihypertensive medications\n- History of allergy or infusion reactions to cetuximab or other monoclonal antibody therapies\n- 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\n- Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents\n- Life expectancy < 12 weeks, as judged by the treating physician"}

Primary endpoints

• {"endpoint_text":"- Compare surgical outcome in terms of margin status between the intervention cohort and the standard of care cohort","definition_or_measurement_approach":"Not explicitly defined in detail; comparison of surgical margin status between cohorts (margin status assessed by pathology and intraoperative fluorescence-guided assessment as implied by objectives)."}

Secondary endpoints

• {"endpoint_text":"- Determining diagnostic parameters (including predictive values, sensitivity, specificity, type I & II errors) of fluorescence imaging for identifying inadequate tumor margins.","definition_or_measurement_approach":"Diagnostic parameters (predictive values, sensitivity, specificity, type I & II errors) of fluorescence imaging for identifying inadequate tumor margins."}
• {"endpoint_text":"- Implementation of an intraoperative feedback workflow between the pathology department and surgery team on the margin assessment by FI.","definition_or_measurement_approach":"Implementation outcome; specific metrics or measurement approach not specified."}
• {"endpoint_text":"- Retrospective comparison between standard fluorescence imaging devices and a novel technique using dual aperture fluorescence imaging as an exploratory objective.","definition_or_measurement_approach":"Retrospective/device-comparison analysis; detailed measurement approach not specified."}

Netherlands

Earliest CTIS Part Ii Submission Date

23-12-2025

Latest Decision Or Authorization Date

03-03-2026

Processing Time Days

70

Number Of Sites

1

Number Of Participants

120

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands