Squamous Cell Carcinoma of the Head and NeckPhase 2GuidedbyLightNCT04191460
Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer
A Phase 2 study testing cRGD-ZW800-1. in people with Squamous Cell Carcinoma of the Head and Neck and Oral Cancer, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck, Oral Cancer, Squamous Cell Carcinoma of the Oral Cavity
- What is being tested?
- cRGD-ZW800-1.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Jul 2022to 22 May 2026
- 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
- Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
- ≥ 18 years of age;
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations;
- Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant.
Who cannot join
- Previous surgery, chemotherapy or radiotherapy to the oral cavity;
- History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.
- Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
- Patients with renal insufficiency (eGFR<60);
- Patients with a previous kidney transplantation in the medical history;
- Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired on weakened immune system, caused by either a pre-existing disease or concomitant medications;
- Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus University Medical Center
Rotterdam, South Holland, 3015 GD
About this study
Official title: Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.
Read the detailed description
Work package I:
In WP-I, the preferred dose of the agent for imaging of margins in oral cancer will be determined. The signal-to-noise ratio will be determined in dose group A (n=7), which will receive 0.05 mg/kg of the tracer, 16-20 hours before surgery. After an interim evaluation of this ratio, the second dose group B (n=7) will receive either a higher or a lower dosage (to be determined) of the tracer. After inclusion of all patients (n=14), the dose with the highest intraoperative signal-to-noise ratio will be selected.
Work package II:
In WP-II, an expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. In this group of 21 patients, it will be determined if FLI can improve the rate of adequate surgical resection margins. As secondary research questions, the following aspects will be assessed:
- sensitivity, specificity, positive and negative predictive values of FLI;
- colocalization with immunohistochemistry;
- change in surgical management; incremental operation time;
- FLI of excised cervical lymph nodes.
- Conditions
- Squamous Cell Carcinoma of the Head and Neck, Oral Cancer, Squamous Cell Carcinoma of the Oral Cavity
- Being tested
- cRGD-ZW800-1.
- Keywords
- cRGD-ZW800-1, fluorescence-guided surgery, image-guided surgery, fluorescence imaging, cancer
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cRGD-ZW800-1.Drug
Injection of cRGD-ZW800-1 within 48 hours before imaging/surgery
| Study group | Role | What they receive |
|---|---|---|
| WP-I dose A | Experimental | n=7. Injection of 0.05 mg/kg cRGD-ZW800-1, within 16-20 hours before imaging/surgery Receives: Drug: cRGD-ZW800-1. |
| WP-I dose B | Experimental | n=7. Injection of (to be determined) mg/kg RGD-ZW800-1, within (to be determined) hours before imaging/surgery. Receives: Drug: cRGD-ZW800-1. |
| WP-II selected dose | Experimental | n=14: expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. Injection of 0.05 ór (to be determined) mg/kg cRGD-ZW800-1, within 48 hours before imaging/surgery. Receives: Drug: cRGD-ZW800-1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
WP-I: (Highest) mean tumor-to-background ratio (TBR)
Two dosages of cRGD-ZW800-1 are tested in two groups of each 7 patients. An expansion cohort (n=14) will be added to the dose group that yields the highest TBR.
Measured: up to 48 ours post-dose
WP-II: Rate of adequate (i.e. >5mm clear) tumor resection margins.
Measured: through histopathology, up to max 4 weeks post-op
Secondary outcomes (5)
WP-II: Sensitivity, specificity, positive and negative predictive values
Measured: through histopathology, up to max 4 weeks post-op
WP-II: Co-localization of FLI with immunohistochemistry on pathology slides
Measured: through histopathology, up to max 4 weeks post-op
WP-II: Percentage of extra tissue resection based on FLI-driven frozen sections
Measured: through histopathology, up to max 4 weeks post-op
WP-II: Operation time
Measured: through histopathology, up to max 4 weeks post-op
WP-II: FLI of lymph node metastases after neck dissection
Measured: through histopathology, up to max 4 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start12 Jul 2022
- Primary completion16 May 2025
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stijn Keereweer, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191460
- Sponsor's protocol ID
- 12175
- Other IDs
- 2019-003416-30, 2019
- Acronym
- GuidedbyLight
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2019
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
- ClinicalTrials.gov ID
- NCT04191460
- Acronym / sponsor ID
- GuidedbyLight / 12175
- Conditions
- Squamous Cell Carcinoma of the Head and Neck, Oral Cancer, Squamous Cell Carcinoma of the Oral Cavity
- Keywords
- cRGD-ZW800-1, fluorescence-guided surgery, image-guided surgery, fluorescence imaging, cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 9 Dec 2019 (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.
This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.
Detailed description
Work package I:
In WP-I, the preferred dose of the agent for imaging of margins in oral cancer will be determined. The signal-to-noise ratio will be determined in dose group A (n=7), which will receive 0.05 mg/kg of the tracer, 16-20 hours before surgery. After an interim evaluation of this ratio, the second dose group B (n=7) will receive either a higher or a lower dosage (to be determined) of the tracer. After inclusion of all patients (n=14), the dose with the highest intraoperative signal-to-noise ratio will be selected.
Work package II:
In WP-II, an expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. In this group of 21 patients, it will be determined if FLI can improve the rate of adequate surgical resection margins. As secondary research questions, the following aspects will be assessed:
- sensitivity, specificity, positive and negative predictive values of FLI;
- colocalization with immunohistochemistry;
- change in surgical management; incremental operation time;
- FLI of excised cervical lymph nodes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WP-I dose A | Experimental | Drug: cRGD-ZW800-1.n=7. Injection of 0.05 mg/kg cRGD-ZW800-1, within 16-20 hours before imaging/surgery |
| WP-I dose B | Experimental | Drug: cRGD-ZW800-1.n=7. Injection of (to be determined) mg/kg RGD-ZW800-1, within (to be determined) hours before imaging/surgery. |
| WP-II selected dose | Experimental | Drug: cRGD-ZW800-1.n=14: expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. Injection of 0.05 ór (to be determined) mg/kg cRGD-ZW800-1, within 48 hours before imaging/surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
- ≥ 18 years of age;
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations;
- Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant.
Key exclusion criteria (7 listed)
- Previous surgery, chemotherapy or radiotherapy to the oral cavity;
- History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.
- Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
- Patients with renal insufficiency (eGFR<60);
- Patients with a previous kidney transplantation in the medical history;
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 |
|---|---|---|
| cRGD-ZW800-1.Injection of cRGD-ZW800-1 within 48 hours before imaging/surgery | Drug | WP-I dose A, WP-I dose B, WP-II selected dose |
Primary outcome
WP-I: (Highest) mean tumor-to-background ratio (TBR)
Time frame: up to 48 ours post-dose
Two dosages of cRGD-ZW800-1 are tested in two groups of each 7 patients. An expansion cohort (n=14) will be added to the dose group that yields the highest TBR.
WP-II: Rate of adequate (i.e. >5mm clear) tumor resection margins.
Time frame: through histopathology, up to max 4 weeks post-op
5 secondary outcomes
WP-II: Sensitivity, specificity, positive and negative predictive values
Time frame: through histopathology, up to max 4 weeks post-op
WP-II: Co-localization of FLI with immunohistochemistry on pathology slides
Time frame: through histopathology, up to max 4 weeks post-op
WP-II: Percentage of extra tissue resection based on FLI-driven frozen sections
Time frame: through histopathology, up to max 4 weeks post-op
WP-II: Operation time
Time frame: through histopathology, up to max 4 weeks post-op
WP-II: FLI of lymph node metastases after neck dissection
Time frame: through histopathology, up to max 4 weeks post-op
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 14 Sep 2026.
- First in-human study of cRGD-ZW800-1 in patients with colorectal cancerLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 cRGD-ZW800-1. in people with Squamous Cell Carcinoma of the Head and Neck and Oral Cancer, run by Erasmus Medical Center 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 7 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 14 Sep 2026. 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?
WP-I: (Highest) mean tumor-to-background ratio (TBR) (time frame: up to 48 ours post-dose). The study lists 2 primary outcomes in all. 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 14 Sep 2026.