IMAGE GUIDED SURGERY FOR MARGIN ASSESSMENT OF HEAD & NECK CANCER USING CETUXIMAB-IRDYE800CW CONJUGATE (ICON)

Phase 2

Completed

• Conditions: squamous cell carcinoma; head & neck cancer; 10027655; 10040900

• Registration Number: NL-OMON47640
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 88

Inclusion Criteria

1) Biopsy confirmed diagnosis of primary or recurrent HNSCC and scheduled to
undergo surgical resection as decided by the Multi-Disciplinary Head & Neck
Tumor Board of the UMCG.
2) Age * 18 years
3) Written informed consent
4) Adequate potential for follow up
5) Acceptable hematologic status, kidney function, and liver function, as
standard surgery protocol requires.

Exclusion Criteria

1) Medical or psychiatric conditions that compromise the patient*s ability to
give informed consent
2) Concurrent uncontrolled medical conditions.
3) Received an investigational drug within 30 days prior to the dose of
cetuximab-IRDye800CW
4) Tumors at sites of which the surgeon would assess that in vivo imaging would
not be feasible
5) Had within 6 months prior to enrollment: myocardial infarction,
cerebrovascular accident, uncontrolled cardiac heart failure, significant liver
disease, unstable angina
6) Inadequately controlled hypertension with or without current
antihypertensive medications.
7) History of infusion reactions to cetuximab or other monoclonal antibody
therapies
8) 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.
9) Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in
males or greater than 450 ms in females)
10) Lab values that in the opinion of the primary surgeon would prevent
surgical resection
11) Patients receiving Class IA (quinidine, procainamide) or Class III
(dofetilide, amiodarone, sotalol) antiarrhythmic agents.
12) Magnesium, potassium and calcium deviations that might lead to cardiac
rhythm (grade II or higher deviations by CTCAE).
13) Life expectancy < 12 weeks
14) Karnofsky performance status < 70%

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective Part 1 (dose finding)<br /><br><br /><br>To determine the optimal dose of cetuximab-IRDye800CW for intra operative<br /><br>imaging with the SurgVision F2 open air NIRF imaging system of easily<br /><br>accessible anatomical areas in the head & neck region, or with a standard<br /><br>nasopharyngeal endoscope coupled to the SurgVision F2 NIRF imaging system for<br /><br>difficult accessible anatomical areas in the head & neck region.<br /><br><br /><br><br /><br>Primary objective Part 2 (main study)<br /><br><br /><br>The main purpose is to establish the intraoperative use of cetuximab-IRDye800CW<br /><br>as a reliable marker for residual tumor in resection margins after surgical<br /><br>removal of HNSCC. The objective is to establish the positive predictive value<br /><br>of cetuximab-IRDye800CW fluorescence as a marker for a tumor positive resection<br /><br>margin.<br /><br><br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p> To determine the threshold level in vivo of cetuximab-IRDye800CW<br /><br>fluorescence for reliable intraoperative deep margins assessment with high<br /><br>sensitivity while ensuring an adequate positive predictive value.<br /><br><br /><br>To quantify sensitivity and positive predictive value of<br /><br>cetuximab-IRDye800CW fluorescence of HNSCC ex vivo using optical molecular<br /><br>imaging and MDSFR/SFF versus fluorescence microscopy and EGFR<br /><br>immunohistochemistry.<br /><br><br /><br>To obtain information on safety aspects of cetuximab-IRDye800CW<br /><br>administration by registration of conjugate blood levels, conjugate integrity,<br /><br>side effects, adverse events (AE), serious adverse events (SAE) and suspected<br /><br>unexpected serious adverse reactions (SUSAR). </p><br>