Patients with squamous cell carcinoma in the head & neck region MedDRA version: 19.1 Level: LLT Classification code 10043516 Term: Throat cancer NOS System Organ Class: 100000004864 MedDRA version: 19.1 Level: LLT Classification code 10077425 Term: Skin cancer excision System Organ Class: 100000004865 MedDRA version: 19.1 Level: LLT Classification code 10023827 Term: Laryngeal cancer NOS System Organ Class: 100000004864 MedDRA version: 19.1 Level: PT Classification code 10068979 Term: Imagin
Conditions
Interventions
Product Name: cetuximab-IRDye800CW
Product Code: cetuximab-800CW
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CETUXIMAB
CAS Number: 205923-56-4
Other descriptive name: cetuximab
Co
Sponsors
University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
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 lower than the lower limit of normal range. 13) Life expectancy < 12 weeks 14) Karnofsky performance status < 70%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main purpose is to establish the intraoperative use of cetuximab-IRDye800CW as a reliable marker for residual tumor in resection margins after surgical removal of head & neck squamous cell carcinoma. The objective is to establish the positive predictive value of cetuximab-IRDye800CW fluorescence as a marker for a tumor positive resection margin.;Secondary Objective: 1) Safety data (cetuximab-IRDye800CW blood levels and conjugate integrity, side effects, AE, SAE, SUSAR); 2) Assessment of the minimal thickness of the non-fluorescent margin of the excised specimen by intraoperative in vivo and ex vivo assessment (SurgVision F2 imaging system, endoscopic NRIF imaging system, MDSFR/SFF) combined with ex vivo examinations (histological examination, NIR flatbed scanning and fluorescence microscopy) ;Primary end point(s): The primary endpoint to calculate the sensitivity and specificity of cetuximab-IRDye800CW-fluorescence of tumor margins by a combination of intraoperative in vivo and ex vivo assessment of the of the surgical wound bed following excision of the primary tumor (SurgVision F2 imaging system, endoscopic NRIF imaging system, MDSFR/SFF) and ex vivo examinations of the acquired biopsies (histological examination, NIR flatbed scanning and fluorescence microscopy);Timepoint(s) of evaluation of this end point: The positive predictive value will be calculated after the total number of patients (70) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1) The occurrunce of SAEs will be evaluated untill 60 minutes after tracer injection. 2) The margin thickness will be calculated after the total number of patients (70);Secondary end point(s): 1) Safety data (cetuximab-IRDye800CW blood levels and conjugate integrity, side effects, AE, SAE, SUSAR); 2) Assessment of the minimal thickness of the non-fluorescent margin of the excised specimen by intraoperative in vivo and ex vivo assessment (SurgVision F2 imaging system, endoscopic NRIF imaging system, MDSFR/SFF) combined with ex vivo examinations (histological examination, NIR flatbed scanning and fluorescence microscopy) | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Oral & Maxillofacial
University Medical Center Groningen
Outcome results
None listed