Unknown Primary TumorsREFLECTNCT06100081
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
A study testing Detection of lesions using fluorescence molecular imaging in people with Unknown Primary Tumors and Oropharynx Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unknown Primary Tumors, Oropharynx Cancer
- What is being tested?
- Detection of lesions using fluorescence molecular imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Apr 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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%.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Max JH Witjes, MD, PhD, +31-50-3616161, m.j.h.witjes@umcg.nl
Floris J Voskuil, MD, PhD, +31-50-3616161, f.j.voskuil@umcg.nl
About this study
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
- Being tested
- Detection of lesions using fluorescence molecular imaging
- Medical subject headings
- Neoplasms, Unknown Primary, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of lesions using fluorescence molecular imagingDiagnostic test
Using a fluorescence camera, lesions will be detected and biopsies will be taken to try and find cancer of unknown primary
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients with cancer of unknown primary most probable originating from the head and neck area Receives: Diagnostic Test: Detection of lesions using fluorescence molecular imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During surgery
Secondary outcomes (7)
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);
Measured: through study completion
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
Measured: Flexible endoscopy will be performed 1-0 days before surgery.
To quantify intrinsic fluorescence signals of cetuximab-800CW;
To quantify intrinsic fluorescence signals of cetuximab-800CW;
Measured: During the procedure
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;
Measured: 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.
To determine the specificity and positive predictive value of TFE and WLE for the detection of the primary tumor in patients with CUP.
Measured: end of study
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.
Measured: 1-2 weeks after procedure
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.
Measured: up to 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start28 Apr 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unknown Primary TumorsStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100081
- Sponsor's protocol ID
- 10949
- Acronym
- REFLECT
- Status last verified
- Oct 2023
- First submitted
- 17 Apr 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06100081
- Acronym / sponsor ID
- REFLECT / 10949
- Conditions
- Unknown Primary Tumors, Oropharynx Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Diagnostic Test: Detection of lesions using fluorescence molecular imagingPatients with cancer of unknown primary most probable originating from the head and neck area |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of lesions using fluorescence molecular imagingUsing a fluorescence camera, lesions will be detected and biopsies will be taken to try and find cancer of unknown primary | Diagnostic test | Patients |
Primary outcome
Accuracy in detecting primary tumours compared to white light endoscopy.
Time frame: During surgery
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
7 secondary outcomes
Safety aspects of cetuximab-800CW
Time frame: through study completion
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.
To quantify intrinsic fluorescence signals of cetuximab-800CW;
Time frame: During the procedure
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
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
To correlate and validate fluorescence signals in vivo and ex vivo with histopathology.
Time frame: 1-2 weeks after procedure
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.
Time frame: up to 6 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detection of lesions using fluorescence molecular imaging in people with Unknown Primary Tumors and Oropharynx Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy in detecting primary tumours compared to white light endoscopy. (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.