Real-time Margin Assessment in Head and Neck Cancer (LIGHTNING)

University Medical Center Groningen (UMCG)

Status and phase

Enrolling

Phase 2

Conditions

Head and Neck Cancer

Head and Neck Squamous Cell Carcinoma

Treatments

Procedure: Fluorescence guided detection of tumor positive margins

Drug: Cetuximab-IRDye800

Study type

Interventional

Funder types

Other

Identifiers

10968

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;