Real-time Margin Assessment in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

— LIGHTNING  

Official title:

Real-time Margin Assessment in Head and Neck Cancer - Enhancing Specificity by Combining Fresh Frozen Sectioning With Targeted Fluorescence Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05499065
• Other study ID #: 10968
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2023
• Est. completion date: January 10, 2025

Study information

• Verified date: April 2024
• Source: University Medical Center Groningen
• Contact: Max JH Witjes, MD, PhD
• Phone: +31-50-3616161
• Email: m.j.h.witjes[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 10, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Procedure:
• Fluorescence guided detection of tumor positive margins
To test if the fluorescence can guide the location for fresh frozen section sampling intra-operatively

Drug:
• Cetuximab-IRDye800
Administrate 75mg cetuximab + 15mg cetuximab-800CW for fluorescence visualization

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enhanced intra-operative margin detection	To determine the feasibility of fluorescence imaging combined with fresh frozen sectioning of a fluorescence guided biopsy of the excised tissue specimen in an on-site intra-operative setting.; Outcome parameter: Detection rate of tumor-positive margins based on standard of care histopathological H/E assessment compared to fresh-frozen section analysis combined with fluorescence	Postoperatively, i.e. 7-10 working days