BridgeMD
Fluorescence Intraoperative Surgical Margin Analysis in Head and Neck Cancer: Clinical Validation
EU CTIS ID: 2025-522027-95-00
What this study is testing
This trial aims to improve and investigate intraoperative margin detection and pathologist-surgeon feedback using fluorescence-guided surgery in head-and-neck cancer patients.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.