visualisation with fluorescence (cetuximab-IRDye800CW) if tumor is left behind after surgical removal in the head & neck area

Phase 1

• Conditions: Patients with squamous cell carcinoma in the head & neck region; MedDRA version: 19.1Level: LLTClassification code 10043516Term: Throat cancer NOSSystem Organ Class: 100000004864; MedDRA version: 19.1Level: LLTClassification code 10077425Term: Skin cancer excisionSystem Organ Class: 100000004865; MedDRA version: 19.1Level: LLTClassification code 10023827Term: Laryngeal cancer NOSSystem Organ Class: 100000004864; MedDRA version: 19.1Level: PTClassification code 10068979Term: Imaging procedureSystem Organ Class: 10022891 - Investigations; MedDRA version: 19.1Level: LLTClassification code 10030961Term: Oral cancer stage unspecifiedSystem Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2016-002726-37-NL
• Lead Sponsor: niversity Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-14
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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%

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified