Real-time Margin Assessment in Head and Neck Cancer

NCT ID: NCT05499065

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-01-10

Brief Summary

To investigate if the combination of fresh frozen sectioning based on cetuximab-800CW can enhance tumor-positive margin detection intra-operatively.

Conditions

Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

75mg cetuximab + 15mg cetuximab-800CW

To investigate if study drugs can assist in tumor-positive margin detection

Group Type: EXPERIMENTAL

Fluorescence guided detection of tumor positive margins

Intervention Type: PROCEDURE

To test if the fluorescence can guide the location for fresh frozen section sampling intra-operatively

Cetuximab-IRDye800

Intervention Type: DRUG

Administrate 75mg cetuximab + 15mg cetuximab-800CW for fluorescence visualization

Interventions

Fluorescence guided detection of tumor positive margins

To test if the fluorescence can guide the location for fresh frozen section sampling intra-operatively

Intervention Type: PROCEDURE

Cetuximab-IRDye800

Administrate 75mg cetuximab + 15mg cetuximab-800CW for fluorescence visualization

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Max J.H. Witjes

Prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Floris J Voskuil, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Max JH Witjes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

Other Identifiers

10968

Identifier Type: -

Identifier Source: org_study_id