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Trial Title:
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
NCT ID:
NCT06100081
Condition:
Unknown Primary Tumors
Oropharynx Cancer
Conditions: Official terms:
Oropharyngeal Neoplasms
Neoplasms, Unknown Primary
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Detection of lesions using fluorescence molecular imaging
Description:
Using a fluorescence camera, lesions will be detected and biopsies will be taken to try
and find cancer of unknown primary
Arm group label:
Patients
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.
Criteria for 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%.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Max JH Witjes, MD, PhD
Phone:
+31-50-3616161
Email:
m.j.h.witjes@umcg.nl
Contact backup:
Last name:
Floris J Voskuil, MD, PhD
Phone:
+31-50-3616161
Email:
f.j.voskuil@umcg.nl
Start date:
April 28, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
University Medical Center Groningen
Agency class:
Other
Source:
University Medical Center Groningen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06100081
