Fluorescence Intraoperative Surgical Margin Analysis in Head and Neck Cancer: Clinical Validation

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Groningen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-01-19

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

National Institutes of Health (NIH), award number: R01DE033449

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Diagnosis

This trial aims to improve and investigate intraoperative margin detection and pathologist-surgeon feedback using fluorescence-guided surgery in head-and-neck cancer patients.

Conditions and MedDRA coding

oral squamous cell carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 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
2. Age ≥ 18 years
3. Written informed consent

Exclusion criteria 9

1. Medical or psychiatric conditions that compromise the patient’s ability to give informed consent as determined by study team
2. Concurrent uncontrolled medical conditions as judged by the primary physician of the patient
3. Participated in a clinical trial in which an investigational drug was administrated within 30 days prior to the dose of cetuximab-800CW
4. History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure with significant risk of cetuximab not being tolerated, as determined by the treating physician
5. Inadequately controlled hypertension – as defined by the treating physician – with or without current antihypertensive medications
6. History of allergy or infusion reactions to cetuximab or other monoclonal antibody therapies
7. 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
8. Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
9. Life expectancy < 12 weeks, as judged by the treating physician

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Compare surgical outcome in terms of margin status between the intervention cohort and the standard of care cohort

Secondary endpoints 3

1. Determining diagnostic parameters (including predictive values, sensitivity, specificity, type I & II errors) of fluorescence imaging for identifying inadequate tumor margins.
2. Implementation of an intraoperative feedback workflow between the pathology department and surgery team on the margin assessment by FI.
3. Retrospective comparison between standard fluorescence imaging devices and a novel technique using dual aperture fluorescence imaging as an exploratory objective.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation

Universitair Medisch Centrum Groningen

Address

Hanzeplein 1

City

Groningen

Postcode

9713 GZ

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Prof. Dr. M.J.H. Witjes

Public contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Prof. Dr. M.J.H. Witjes

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications