Real time Molecular Fluorescence and Narrow Band Imaging for detection of the Primary Cancer Lesion in Patients with a Metastatis of Unknown Primary Tumor in the Head and Neck

Phase 2

• Conditions: cancer of unknown primary; head & neck cancer; 10027656

• Registration Number: NL-OMON54715
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

- Cytology confirmed diagnosis of squamous cell carcinoma and scheduled to
undergo panendoscopy as decided by the Multi-Disciplinary Head and Neck Tumor
Board of the UMCG;
- The primary tumor was not identified during standard diagnostic work-up in
the outpatient clinic including physical head and neck examination,
laryngoscopy, X-thorax and CT, PET or MRI;
- Age >= 18 years;
- Written informed consent;
- Mentally competent person that is able and willing to comply with study
procedures.

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;
- History of myocardial infarction, cerebrovascular accident, uncontrolled
cardiac heart failure, significant liver disease or unstable angina within 6
months prior to enrollment;
- 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);
- Patients receiving Class IA (quinidine, procainamide) or Class III
(dofetilide, amiodarone, sotalol) antiarrhythmic agents;
- Clinically significant abnormalities in magnesium, potassium and calcium
levels;
- Life expectancy < 12 weeks;
- Karnofsky performance status < 70%.

Study & Design

• Study Type: Interventional
• Study Design: Not specified