NCT05499065

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Mar 2023

Shorter than P25 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

August 8, 2022

Last Update Submit

May 27, 2025

Conditions

Head and Neck CancerHead and Neck Squamous Cell Carcinoma

Keywords

Cetuximab-800CWFluorescence guided surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

75mg cetuximab + 15mg cetuximab-800CW

EXPERIMENTAL

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

Procedure: Fluorescence guided detection of tumor positive marginsDrug: Cetuximab-IRDye800

Interventions

Fluorescence guided detection of tumor positive marginsPROCEDURE

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

75mg cetuximab + 15mg cetuximab-800CW
Cetuximab-IRDye800DRUG

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

75mg cetuximab + 15mg cetuximab-800CW

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Floris J Voskuil, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

  • Max JH Witjes, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 12, 2022

Study Start

March 1, 2023

Primary Completion

October 23, 2024

Study Completion

January 10, 2025

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)