Using real-time fluorescence imaging to find unknown primary tumors in the head and neck

Real-time Targeted Fluorescence Endoscopy for Detection of the Primary Cancer Lesion in Patients With a Metastasis of Unknown Primary Tumor in the Head and Neck

This study is testing a new way to find hidden tumors in the head and neck of patients with cancer of unknown primary by using special imaging technology during an endoscopy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Medical Center Groningen (Academic / other)
• Drugs / interventions: cetuximab, radiation
• Locations: 1 site (Groningen)
• Trial ID: NCT06100081 on ClinicalTrials.gov

What this trial studies

This study aims to improve the detection of primary tumors in patients with cancer of unknown primary (CUP) in the head and neck region. It utilizes targeted fluorescence endoscopy, a technique that enhances visualization of tumor-specific biomarkers, to differentiate between normal mucosa and tumor tissue. By identifying the primary tumor, the study seeks to minimize unnecessary treatments and improve patient outcomes. Participants will undergo endoscopy to detect lesions that were not identified during standard diagnostic procedures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with cytology or histology-confirmed squamous cell carcinoma of the head and neck, who have not had their primary tumor identified through standard diagnostic work-up.

Not a fit: Patients with uncontrolled medical conditions or those who have recently received investigational drugs may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate identification of primary tumors, reducing unnecessary treatments and improving patient outcomes.

How similar studies have performed: While the use of fluorescence imaging in cancer detection is promising, this specific application for unknown primary tumors in the head and neck is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion 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;

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-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.
* Life expectancy \< 12 weeks;
* Karnofsky performance status \< 70%.

Where this trial is running

Groningen

• University Medical Center Groningen — Groningen, Netherlands (Recruiting)

Conditions Unknown Primary Tumors; Oropharynx Cancer