Head and Neck CancerPhase 2LIGHTNINGNCT05499065
Real-time Margin Assessment in Head and Neck Cancer
A Phase 2 study testing Fluorescence guided detection of tumor positive margins and Cetuximab-IRDye800 in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
To investigate if the combination of fresh frozen sectioning based on cetuximab-800CW can enhance tumor-positive margin detection intra-operatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Fluorescence guided detection of tumor positive margins and Cetuximab-IRDye800
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2023to 10 Jan 2025
- Phase
- Phase 2
- 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 oral squamous cell carcinoma and scheduled to undergo surgical removal as decided by the multidisciplinary head and neck tumor board of the UMCG;
- 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 1a (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Life expectancy < 12 weeks;
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9713 GZ
About this study
Official title: Real-time Margin Assessment in Head and Neck Cancer - Enhancing Specificity by Combining Fresh Frozen Sectioning With Targeted Fluorescence Imaging
To investigate if the combination of fresh frozen sectioning based on cetuximab-800CW can enhance tumor-positive margin detection intra-operatively.
- Being tested
- Fluorescence guided detection of tumor positive margins, Cetuximab-IRDye800
- Keywords
- Cetuximab-800CW, Fluorescence guided surgery
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence guided detection of tumor positive marginsProcedure or surgery
To test if the fluorescence can guide the location for fresh frozen section sampling intra-operatively
Cetuximab-IRDye800Drug
Administrate 75mg cetuximab + 15mg cetuximab-800CW for fluorescence visualization
| Study group | Role | What they receive |
|---|---|---|
| 75mg cetuximab + 15mg cetuximab-800CW | Experimental | To investigate if study drugs can assist in tumor-positive margin detection Receives: Procedure: Fluorescence guided detection of tumor positive margins; Drug: Cetuximab-IRDye800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhanced intra-operative margin detection
To determine the feasibility of fluorescence imaging combined with fresh frozen sectioning of a fluorescence guided biopsy of the excised tissue specimen in an on-site intra-operative setting.
Outcome parameter: Detection rate of tumor-positive margins based on standard of care histopathological H/E assessment compared to fresh-frozen section analysis combined with fluorescence
Measured: Postoperatively, i.e. 7-10 working days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Mar 2023
- Primary completion23 Oct 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max J.H. Witjes, University Medical Center Groningen
- Investigators
- Floris J Voskuil, MD, PhD, Principal investigator, University Medical Center GroningenMax JH Witjes, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499065
- Sponsor's protocol ID
- 10968
- Acronym
- LIGHTNING
- Status last verified
- May 2025
- First submitted
- 8 Aug 2022
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Margin Assessment in Head and Neck Cancer - Enhancing Specificity by Combining Fresh Frozen Sectioning With Targeted Fluorescence Imaging
- ClinicalTrials.gov ID
- NCT05499065
- Acronym / sponsor ID
- LIGHTNING / 10968
- Keywords
- Cetuximab-800CW, Fluorescence guided surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 12 Aug 2022 (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.
To investigate if the combination of fresh frozen sectioning based on cetuximab-800CW can enhance tumor-positive margin detection intra-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 75mg cetuximab + 15mg cetuximab-800CW | Experimental | Procedure: Fluorescence guided detection of tumor positive margins, Drug: Cetuximab-IRDye800To investigate if study drugs can assist in tumor-positive margin detection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cytology and/or histology-confirmed diagnosis of oral squamous cell carcinoma and scheduled to undergo surgical removal as decided by the multidisciplinary head and neck tumor board of the UMCG;
- Age ≥ 18 years;
- Written informed consent.
Key exclusion criteria (10 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 |
|---|---|---|
| Fluorescence guided detection of tumor positive marginsTo test if the fluorescence can guide the location for fresh frozen section sampling intra-operatively | Procedure or surgery | 75mg cetuximab + 15mg cetuximab-800CW |
| Cetuximab-IRDye800Administrate 75mg cetuximab + 15mg cetuximab-800CW for fluorescence visualization | Drug | 75mg cetuximab + 15mg cetuximab-800CW |
Primary outcome
Enhanced intra-operative margin detection
Time frame: Postoperatively, i.e. 7-10 working days
To determine the feasibility of fluorescence imaging combined with fresh frozen sectioning of a fluorescence guided biopsy of the excised tissue specimen in an on-site intra-operative setting. Outcome parameter: Detection rate of tumor-positive margins based on standard of care histopathological H/E assessment compared to fresh-frozen section analysis combined with fluorescence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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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.
Floris J Voskuil, MD, PhD principal investigator
University Medical Center Groningen
Max JH Witjes, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluorescence guided detection of tumor positive margins and Cetuximab-IRDye800 in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 31 May 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enhanced intra-operative margin detection (time frame: Postoperatively, i.e. 7-10 working days). 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 31 May 2025.