Image Guided Surgery for Margin Assessment of Head and Neck Cancer Using Cetuximab-IRDye800CW cONjugate (ICON)
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ClinicalTrials.gov Identifier: NCT03134846 |
Recruitment Status :
Recruiting
First Posted : May 1, 2017
Last Update Posted : May 3, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Squamous Cell Carcinoma Margin Assessment | Drug: Cetuximab-IRDye800CW | Phase 1 Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 79 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Phase 1: 3x3 Dose-escalation with 3 different doses Cetuximab-IRDye800CW Phase 2: Prospective cross sectional diagnostic study. After having established the optimal cetuximab-IRDye800CW dose we will extent the study by including up to 70 patients. |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Image Guided Surgery for Margin Assessment of Head and Neck Cancer Using Cetuximab-IRDye800CW cONjugate |
Actual Study Start Date : | December 16, 2017 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | June 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Phase 1: 10mg Cetuximab-IRDye800CW
Three patients will receive 10mg Cetuximab-IRDye800cv I.V. four days prior to surgery.
|
Drug: Cetuximab-IRDye800CW
Pre-operatively administration of Cetuximab-IRDye800CW for intra operative margin assessment using a fluorescent antibody-based optical tracer
Other Name: Cetuximab-800cw |
Experimental: Phase 1: 25mg Cetuximab-IRDye800CW
Patients will receive 25mg Cetuximab-IRDye800cv I.V. four days prior to surgery.
|
Drug: Cetuximab-IRDye800CW
Pre-operatively administration of Cetuximab-IRDye800CW for intra operative margin assessment using a fluorescent antibody-based optical tracer
Other Name: Cetuximab-800cw |
Experimental: Phase 1: 50 mg Cetuximab-IRDye800CW
Patients will receive 50mg Cetuximab-IRDye800cv I.V. four days prior to surgery.
|
Drug: Cetuximab-IRDye800CW
Pre-operatively administration of Cetuximab-IRDye800CW for intra operative margin assessment using a fluorescent antibody-based optical tracer
Other Name: Cetuximab-800cw |
Experimental: Phase 1: 75mg cetuximab + 15 mg Cetuximab-IRDye800CW
Patients will receive 75mg cetuximab + 15 mg Cetuximab-IRDye800CW I.V. four days prior to surgery.
|
Drug: Cetuximab-IRDye800CW
Pre-operatively administration of Cetuximab-IRDye800CW for intra operative margin assessment using a fluorescent antibody-based optical tracer
Other Name: Cetuximab-800cw |
Experimental: Phase 1: 75mg cetuximab + 25 mg Cetuximab-IRDye800CW
Patients will receive 75mg cetuximab + 25 mg Cetuximab-IRDye800CW I.V. four days prior to surgery.
|
Drug: Cetuximab-IRDye800CW
Pre-operatively administration of Cetuximab-IRDye800CW for intra operative margin assessment using a fluorescent antibody-based optical tracer
Other Name: Cetuximab-800cw |
Experimental: After having established the optimal cetuximab-IRDye800CW dose
After having established the optimal cetuximab-IRDye800CW dose we will extent the study by including up to 70 patients for this specific dose (as determined in phase 1).
|
Drug: Cetuximab-IRDye800CW
Pre-operatively administration of Cetuximab-IRDye800CW for intra operative margin assessment using a fluorescent antibody-based optical tracer
Other Name: Cetuximab-800cw |
- Phase 1: Determine the optimal dose of Cetuximab-IRDye800CW for imaging [ Time Frame: Five months ]The primary endpoint for the feasibility study (9 patients) will be confirmation of the clinically applicable dose of cetuximab-IRDye800CW. The aim is to obtain at least a TBR higher than 2 by fluorescence imaging with the intra operative camera. This number has been found to give sufficient demarcation of tumor to normal tissue on wide field images.
- Phase 2: Threshold level of fluorescence [ Time Frame: Three years ]Determine a threshold level of fluorescence that can discriminate between EGFR distribution in normal tissue and a margin with EGFR-positive tumor.
- Phase 1: Secondary outcome: Safety [ Time Frame: Five months ]Adverse events will be monitored
- Phase 1: Secondary outcome: Identification of positive margins [ Time Frame: Five months ]By ex vivo imaging and MDSFR spectroscopy of the excised specimen
- Phase 1: Tissue specificity of IRDye800cw [ Time Frame: Five months ]Identification of the tissues that show IRDye800CW-fluorescence in the surgical wound bed after tumor removal
- Phase 1: Histological location of IRDye800cw [ Time Frame: Five months ]Localisation patterns of cetuximab-IRDye800CW in the tumor and normal tissue by microscopy
- Phase 2: Secondary outcome: Minimal thickness of the non-fluorescent margin [ Time Frame: Three years ]The assessment of the minimal thickness of the non-fluorescent margin of the excised specimen with histopathology and fluorescence microscopy. This will provide us the first data on the relationship between margin thickness when fluorescence cannot be detected.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria
- Biopsy confirmed diagnosis of primary or recurrent HNSCC and scheduled to undergo surgical resection as decided by the Multi-Disciplinary Head and Neck Tumor Board of the UMCG.
- Age ≥ 18 years
- Written informed consent
- Adequate potential for follow up
- Acceptable hematologic status, kidney function, and liver function, as standard surgery protocol requires.
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-IRDye800CW
- Tumors at sites of which the surgeon would assess that in vivo imaging would not be feasible
- Had within 6 months prior to enrollment: myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease, unstable angina
- Inadequately controlled hypertension with or without current antihypertensive medications.
- History of infusion reactions to cetuximab or other monoclonal antibody therapies
- Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. 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)
- Lab values that in the opinion of the primary surgeon would prevent surgical resection.
- Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Magnesium, potassium and calcium lower than the lower limit of normal range.
- Life expectancy < 12 weeks
- Karnofsky performance status < 70%

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134846
Contact: Max J.H. Witjes, MD, PhD | +31-50-3613841 | m.j.h.witjes@umcg.nl | |
Contact: Floris J. Voskuil, MD | +31-50-3655170 | f.j.voskuil@umcg.nl |
Netherlands | |
University Medical Center Groningen | Recruiting |
Groningen, Netherlands, 9713 GZ | |
Contact: Max J.H. Witjes, MD, PhD m.j.h.witjes@umcg.nl | |
Contact: Floris J. Voskuil, MD +31-50-3610030 f.j.voskuil@umcg.nl |
Responsible Party: | dr. M.J.H. Witjes, MD, PhD, University Medical Center Groningen |
ClinicalTrials.gov Identifier: | NCT03134846 |
Other Study ID Numbers: |
NL58585.042.16 |
First Posted: | May 1, 2017 Key Record Dates |
Last Update Posted: | May 3, 2021 |
Last Verified: | April 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Intraoperative fluorescence imaging Cetuximab-IRDye800CW Molecular imaging |
Head and Neck Neoplasms Squamous Cell Carcinoma of Head and Neck Carcinoma, Squamous Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms by Site Cetuximab Antineoplastic Agents, Immunological Antineoplastic Agents |