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

NCT06100081 | Unknown

• 1 other identifier: 10949
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

In current diagnostic work-up of patients with a cancer of unknown primary (CUP), approximately 50% of the primary tumor lesions remains undetected. Identification of the primary tumor site results in minimizing the potential morbidity from treatment by reducing morbidity by omitting the need for a mucosectomy of the bilateral base of tongue and tonsils, reducing the radiation field and better oncologic outcome than those with unidentified primary tumor. Clearly, new endoscopic 'real-time' imaging techniques are needed to visualize mucosal changes associated with head and neck squamous cell carcinoma and increase detection rate of the primary tumor. Targeted fluorescence endoscopy enables the visualization of targeted tumor-specific biomarkers by using fluorescence, thereby enhancing the contrast between normal mucosa and tumor tissue. This could improve the detection of the primary tumor in cases where the primary tumor is not detected with white light endoscopy.

Conditions

Unknown Primary Tumors; Oropharynx Cancer

Outcome Measures

Primary Outcomes (1)

• Accuracy in detecting primary tumours compared to white light endoscopy.

  To determine the feasibility of targeted fluorescence endoscopy compared to white light endoscopy and a mucosectomy using cetuximab-800CW for the detection of the primary tumor in patients with CUP

  During surgery

Secondary Outcomes (7)

• Safety aspects of cetuximab-800CW

  through study completion

• Accuracy in detecting primary tumours with flexible fluorescence laryngoscopy at the outpatient clinic for primary tumor detection rates

  Flexible endoscopy will be performed 1-0 days before surgery.

• To quantify intrinsic fluorescence signals of cetuximab-800CW;

  During the procedure

• To determine if ex vivo fluorescence imaging using cetuximab-800CW can be used for assessment of the surgical specimen after mucosectomy;

  immediatly after the procedure

• To determine the specificity and positive predictive value of TFE and WLE for the detection of the primary tumor in patients with CUP.

  end of study

Study Arms (1)

Patients

EXPERIMENTAL

Patients with cancer of unknown primary most probable originating from the head and neck area

Diagnostic Test: Detection of lesions using fluorescence molecular imaging

Interventions

Detection of lesions using fluorescence molecular imaging DIAGNOSTIC_TEST

Using a fluorescence camera, lesions will be detected and biopsies will be taken to try and find cancer of unknown primary

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify if:

• 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%.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Neoplasms, Unknown Primary; Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: October 25, 2023
• Study Start: April 28, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

NL (1)