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Targeted fluorescence endoscopy for detection of the primary cancer lesion in patients with a metastasis of unknown primary tumor in the head and neck
EU CTIS ID: 2024-513897-23-00
What this study is testing
To study the feasibility of identifying primary tumors in the upper aerodigestive tract in patients with unknown primary cancer with the use of targeted fluorescence endoscopy with cetuximab-800CW as the fluorescent tracer
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Cytology and/or histology-confirmed diagnosis of squamous cell carcinoma most likely originating from the head & neck area and scheduled to undergo endoscopy of the upper aerodigestive tract as decided by the multidisciplinary 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, fiberoptic laryngoscopy, chest X-ray, CT and PET/CT
- Age ≥ 18 years
- Written informed consent
You likely can't join if
- Medical or psychiatric conditions that compromise the patient’s ability to give informed consent
- Life expectancy < 12 weeks
- Karnofsky performance status < 70%
- Concurrent uncontrolled medical conditions
- Received an investigational drug within 30 days prior to the dose of cetuximab-800CW
- History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease (ALT >3X upper limits of normal or increased total bilirubin) or unstable angina within 6 months prior to enrollment
See the full eligibility criteria
- Cytology and/or histology-confirmed diagnosis of squamous cell carcinoma most likely originating from the head & neck area and scheduled to undergo endoscopy of the upper aerodigestive tract as decided by the multidisciplinary 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, fiberoptic laryngoscopy, chest X-ray, CT and PET/CT
- Age ≥ 18 years
- Written informed consent
- Medical or psychiatric conditions that compromise the patient’s ability to give informed consent
- Life expectancy < 12 weeks
- Karnofsky performance status < 70%
- Concurrent uncontrolled medical conditions
- Received an investigational drug within 30 days prior to the dose of cetuximab-800CW
- History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease (ALT >3X upper limits of normal or increased total bilirubin) or unstable angina within 6 months prior to enrollment
- Inadequately controlled hypertension with or without current antihypertensive medications
- History of allergy or infusion reactions cetuximab or other monoclonal antibody therapies
- Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. Moreover, the need to be willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter. 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.