Improving tumor margin detection in head and neck cancer surgery
Real-time Margin Assessment in Head and Neck Cancer - Enhancing Specificity by Combining Fresh Frozen Sectioning With Targeted Fluorescence Imaging
This study is testing a new way to help doctors find and remove all the cancer during surgery for head and neck cancer by using a special dye and real-time feedback on tumor edges.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | cetuximab |
| Locations | 1 site (Groningen) |
| Trial ID | NCT05499065 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of fluorescence guided surgery combined with cetuximab-800CW to enhance the detection of tumor-positive margins during surgical procedures for head and neck cancer. By utilizing real-time margin assessment, the goal is to improve surgical outcomes and reduce the likelihood of residual cancerous tissue. Patients with confirmed oral squamous cell carcinoma who are scheduled for surgical removal will be included in the study. The approach aims to provide surgeons with immediate feedback on tumor margins, potentially leading to more effective surgeries.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of oral squamous cell carcinoma scheduled for surgical intervention.
Not a fit: Patients with uncontrolled medical conditions, recent investigational drug use, or significant cardiac or liver issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more complete tumor removals and better outcomes for patients with head and neck cancer.
How similar studies have performed: While the use of fluorescence guided surgery is gaining traction, this specific combination with cetuximab-800CW is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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: * Medical or psychiatric conditions that compromise the patient's ability to give informed consent; * Concurrent uncontrolled medical conditions; * Received an investigational drug within 30 days prior to the dose of cetuximab-800CW; * History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease (ALT \>3X upper limits of normal or increased total bilirubin) or unstable angina within 6 months prior to enrollment; * Inadequately controlled hypertension with or without current antihypertensive medications; * History of allergy or infusion reactions 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; * Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females) * Patients receiving Class 1a (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. * Life expectancy \< 12 weeks;
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Floris J Voskuil, MD, PhD — University Medical Center Groningen
- Study coordinator: Max JH Witjes, MD, PhD
- Email: m.j.h.witjes@umcg.nl
- Phone: +31-50-3616161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.