2025-522027-95-00
Not yet recruiting
Phase 3
Fluorescence Intraoperative Surgical Margin Analysis in Head and Neck Cancer: Clinical Validation
Universitair Medisch Centrum Groningen1 site in 1 country120 target enrollmentStarted: January 19, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Compare surgical outcome in terms of margin status between the intervention cohort and the standard of care cohort
Overview
Brief Summary
This trial aims to improve and investigate intraoperative margin detection and pathologist-surgeon feedback using fluorescence-guided surgery in head-and-neck cancer patients.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Compare surgical outcome in terms of margin status between the intervention cohort and the standard of care cohort
Compare surgical outcome in terms of margin status between the intervention cohort and the standard of care cohort
Secondary Outcomes
- 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.
Investigators
Prof. Dr. M.J.H. Witjes
Scientific
Universitair Medisch Centrum Groningen
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Phase 1/2
The STELLAR trial: Fluorescence-guided surgery in laryngeal- and hypopharyngeal cancer: a feasibility trial2024-519750-36-00Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)27
Not yet recruiting
Not Applicable
A Prospective Clinical Study Investigating the Use of the Histolog Scanner for Intraoperative Assessment of Surgical Margins in Patients Undergoing Breast-conserving Surgery for Histologically Confirmed Breast Cancer. The Histolog Scanner Operates on the Principle of Confocal MicroscopNCT07341542Silesian Hospital in Opava20
Not yet recruiting
Not Applicable
Novel Humanized Ferritin-based NIR Fluorescent Molecular Probe for Identifying Tumor Margins in Gastric TissueNCT07276854Nanfang Hospital, Southern Medical University32
Not yet recruiting
Not Applicable
Cellular-Level Fluorescence Imaging for Intraoperative Margin Assessment in Breast CancerNCT07311317West China Hospital165
Recruiting
Not Applicable
Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence MicroscopyBasal Cell CarcinomaNCT06473103University of Rochester52