LIGHTNING: Real-time Margin Assessment in Head and Neck Cancer

Sponsor

University Medical Center Groningen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05499065

Collaborator

(none)

Enrollment

Location

Arm

24.3

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Head and Neck Squamous Cell Carcinoma	Procedure: Fluorescence guided detection of tumor positive margins Drug: Cetuximab-IRDye800	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 10, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 75mg cetuximab + 15mg cetuximab-800CW To investigate if study drugs can assist in tumor-positive margin detection	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

Arm

Intervention/Treatment

Experimental: 75mg cetuximab + 15mg cetuximab-800CW

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

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

Outcome Measures

Primary Outcome Measures

Enhanced intra-operative margin detection [Postoperatively, i.e. 7-10 working days]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Groningen	Groningen		Netherlands	9713 GZ

Sponsors and Collaborators

University Medical Center Groningen

Investigators

Principal Investigator: Floris J Voskuil, MD, PhD, University Medical Center Groningen
Principal Investigator: Max JH Witjes, MD, PhD, University Medical Center Groningen