Back to resultsReal-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 (REFLECT)
Primary Purpose
Unknown Primary Tumors, Oropharynx Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Detection of lesions using fluorescence molecular imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Unknown Primary Tumors
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%.
Sites / Locations
- University Medical Center GroningenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Patients with cancer of unknown primary most probable originating from the head and neck area
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Safety aspects of cetuximab-800CW
To obtain information on safety aspects of cetuximab-800CW administration by registration of side effects, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR);
Accuracy in detecting primary tumours with flexible fluorescence laryngoscopy at the outpatient clinic for primary tumor detection rates
Accuracy in detecting primary tumours with flexible fluorescence laryngoscopy at the outpatient clinic for primary tumor detection rates
To quantify intrinsic fluorescence signals of cetuximab-800CW;
To quantify intrinsic fluorescence signals of cetuximab-800CW;
To determine if ex vivo fluorescence imaging using cetuximab-800CW can be used for assessment of the surgical specimen after mucosectomy;
To determine if ex vivo fluorescence imaging using cetuximab-800CW can be used for assessment of the surgical specimen after mucosectomy;
To determine the specificity and positive predictive value of TFE and WLE for the detection of the primary tumor in patients with CUP.
To determine the specificity and positive predictive value of TFE and WLE for the detection of the primary tumor in patients with CUP.
To correlate and validate fluorescence signals in vivo and ex vivo with histopathology.
To correlate and validate fluorescence signals in vivo and ex vivo with histopathology.
To study health-related quality of life data regarding the standard of care mucosectomy procedures performed with transoral robot surgery using the QLQ-C30, QLQH&N35 en de SWAL-QoL.
To study health-related quality of life data regarding the standard of care mucosectomy procedures performed with transoral robot surgery.
Full Information
NCT ID
NCT06100081
First Posted
April 17, 2023
Last Updated
October 20, 2023
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT06100081
Brief 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
Acronym
REFLECT
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unknown Primary Tumors, Oropharynx Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Patients with cancer of unknown primary most probable originating from the head and neck area
Intervention Type
Diagnostic Test
Intervention Name(s)
Detection of lesions using fluorescence molecular imaging
Intervention Description
Using a fluorescence camera, lesions will be detected and biopsies will be taken to try and find cancer of unknown primary
Primary Outcome Measure Information:
Title
Accuracy in detecting primary tumours compared to white light endoscopy.
Description
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
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Safety aspects of cetuximab-800CW
Description
To obtain information on safety aspects of cetuximab-800CW administration by registration of side effects, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR);
Time Frame
through study completion
Title
Accuracy in detecting primary tumours with flexible fluorescence laryngoscopy at the outpatient clinic for primary tumor detection rates
Description
Accuracy in detecting primary tumours with flexible fluorescence laryngoscopy at the outpatient clinic for primary tumor detection rates
Time Frame
Flexible endoscopy will be performed 1-0 days before surgery.
Title
To quantify intrinsic fluorescence signals of cetuximab-800CW;
Description
To quantify intrinsic fluorescence signals of cetuximab-800CW;
Time Frame
During the procedure
Title
To determine if ex vivo fluorescence imaging using cetuximab-800CW can be used for assessment of the surgical specimen after mucosectomy;
Description
To determine if ex vivo fluorescence imaging using cetuximab-800CW can be used for assessment of the surgical specimen after mucosectomy;
Time Frame
immediatly after the procedure
Title
To determine the specificity and positive predictive value of TFE and WLE for the detection of the primary tumor in patients with CUP.
Description
To determine the specificity and positive predictive value of TFE and WLE for the detection of the primary tumor in patients with CUP.
Time Frame
end of study
Title
To correlate and validate fluorescence signals in vivo and ex vivo with histopathology.
Description
To correlate and validate fluorescence signals in vivo and ex vivo with histopathology.
Time Frame
1-2 weeks after procedure
Title
To study health-related quality of life data regarding the standard of care mucosectomy procedures performed with transoral robot surgery using the QLQ-C30, QLQH&N35 en de SWAL-QoL.
Description
To study health-related quality of life data regarding the standard of care mucosectomy procedures performed with transoral robot surgery.
Time Frame
up to 6 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%.
Facility Information:
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Max JH Witjes, MD, PhD
Phone
+31-50-3616161
Email
m.j.h.witjes@umcg.nl
First Name & Middle Initial & Last Name & Degree
Floris J Voskuil, MD, PhD
Phone
+31-50-3616161
Email
f.j.voskuil@umcg.nl
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
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