Squamous Cell Carcinoma of the LarynxPhase 2STELLARNCT05752149
Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial
A Phase 2 study testing CRGD-ZW800-1 in people with Squamous Cell Carcinoma of the Larynx and Squamous Cell Carcinoma of the Hypopharynx, run by Erasmus Medical Center at 2 sites in Netherlands.
Trial summary
This is an open-label, single-dose, prospective clinical trial. The study comprises 2 work packages. The main objective of work package I (WP-1) is to assess feasibility of Fluorescence imaing (FLI) during total laryngectomy (TLE) and to assess the optimal dose of the 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 Larynx, Squamous Cell Carcinoma of the Hypopharynx
- 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
- 27 participants
- Where
- 2 sitesNetherlands
- Study dates
- 31 Mar 2026to 31 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 Laryngeal and hypopharyngeal cancer, eligible for surgical resection of the tumor by TLE;
- ≥ 18 years of age;
- Written informed consent must be obtained;
- Sufficient knowledge of the Dutch language to understand the informed consent form;
Who cannot join
- History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent;
- Other synchronous biopsy proven malignancies currently active, except for adequately treated in situ carcinoma of cervix and basal, squamous cell skin carcinoma, or other head- and neck squamous cell cancer;
- Patients pregnant or breastfeeding;
- Patients with renal insufficiency (defined as eGFR < 60);
- Patients with previous kidney transplantation or a solitary functioning kidney;
- Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2 inhibitors), that cannot be paused during the course of the study;
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- Patients with ASA classification of 4 or higher;
- Patients with measured QTc of 500 ms or higher at screening;
- Patients with laboratory abnormalities defined as:
- Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or;
- Total bilirubin above 3 times the ULN or;
- Platelet count below 100 x 109/L or;
- Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males).
- Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired or weakened immune system, caused by either a preexisting disease or concomitant medications;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015GD
Stijn Keereweer, MD, PhD
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015GD
Stijn Keereweer, MD, PhD, 0107041357, s.keereweer@erasmusmc.nl
About this study
Official title: The STELLAR Trial: Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial
This is an open-label, single-dose, prospective clinical trial. The study comprises 2 work packages. The main objective of work package I (WP-1) is to assess feasibility of Fluorescence imaing (FLI) during total laryngectomy (TLE) and to assess the optimal dose of the cRGD-ZW800-1. Work package II (WP-II) is designed to assess whether FLI can detect and decrease tumor positive margins after a TLE.
Read the detailed description
This is a two staged clinical trial to investigate intraoperative fluorescence imaging in patientsundergoing TLE. WP-I is a dose finding study in which 2 doses will be tested with a possibility of a third dosing group. Every dosing cohort comprises 3 patients. After WP-I, an interim analysis will be performed to decide the optimal dose.
The optimal dose will be based on the TBR and the performance in detecting the most close margin (i.e. 'the sentinel margin'). A TBR of at least 1.5 is required for the optimal dose. If a positive margin is missed with fluorescence imaging, the concerned dose will be defined as suboptimal.
WP-II is an extension cohort of the optimal dose cohort selected in WP-I. WP-II will comprise of 18 patients.
The endpoints for WP-II are:
- the rate of tumor free resection margins based on the current golden standard;
- Sensitivity, specificity and positive predictive value of FLI;
- The intraoperative change in surgical management based on FLI;
- FLI of excised cervical lymph nodes;
- Influence of previous radiotherapy on the FLI performance;
- Adverse events and toxicity after intravenous injection with cRGD-ZW800-1;
- Being tested
- CRGD-ZW800-1
- Keywords
- Tumour specific fluorescence imaging
- Medical subject headings
- 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.
CRGD-ZW800-1Drug
Intravenous administration of study drug at lesat 2h prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| 0.05 mg/kg cRGD-ZW800-1 | Experimental | n=3. Injection of 0.05 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery Receives: Drug: CRGD-ZW800-1 |
| 0.025 mg/kg cRGD-ZW800-1 | Experimental | n=3. Injection of 0.025 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery Receives: Drug: CRGD-ZW800-1 |
| 0.01 mg/kg cRGD-ZW800-1 | Experimental | n=3. Injection of 0.01 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery. Receives: Drug: CRGD-ZW800-1 |
| Expansion Cohort | Experimental | n=18: expansion cohort will be added to the group of patients that had received the selected dose in WP-I. Receives: Drug: CRGD-ZW800-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
WP-I: the optimal dose of cRGD-ZW800-1 for FLI of laryngeal and hypopharyngeal cancer
Based on the tumor-to-background ratio (TBR) on breadloaves. Higher TBRs indicate a better outcome
Measured: Up to 48 hours after administration (Depending on pathology grossing)
WP-II: the rate of clear tumor resection margins
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 posted2 Mar 2023
- Study start31 Mar 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
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 LarynxStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 27 participants (estimated)
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
- NCT05752149
- Sponsor's protocol ID
- NL74742.078.21
- Acronym
- STELLAR
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Uponr reasonable reasonable request
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
- The STELLAR Trial: Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial
- ClinicalTrials.gov ID
- NCT05752149
- Acronym / sponsor ID
- STELLAR / NL74742.078.21
- Keywords
- Tumour specific fluorescence imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 2 Mar 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.
This is an open-label, single-dose, prospective clinical trial. The study comprises 2 work packages. The main objective of work package I (WP-1) is to assess feasibility of Fluorescence imaing (FLI) during total laryngectomy (TLE) and to assess the optimal dose of the cRGD-ZW800-1. Work package II (WP-II) is designed to assess whether FLI can detect and decrease tumor positive margins after a TLE.
Detailed description
This is a two staged clinical trial to investigate intraoperative fluorescence imaging in patientsundergoing TLE. WP-I is a dose finding study in which 2 doses will be tested with a possibility of a third dosing group. Every dosing cohort comprises 3 patients. After WP-I, an interim analysis will be performed to decide the optimal dose.
The optimal dose will be based on the TBR and the performance in detecting the most close margin (i.e. 'the sentinel margin'). A TBR of at least 1.5 is required for the optimal dose. If a positive margin is missed with fluorescence imaging, the concerned dose will be defined as suboptimal.
WP-II is an extension cohort of the optimal dose cohort selected in WP-I. WP-II will comprise of 18 patients.
The endpoints for WP-II are:
- the rate of tumor free resection margins based on the current golden standard;
- Sensitivity, specificity and positive predictive value of FLI;
- The intraoperative change in surgical management based on FLI;
- FLI of excised cervical lymph nodes;
- Influence of previous radiotherapy on the FLI performance;
- Adverse events and toxicity after intravenous injection with cRGD-ZW800-1;
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.05 mg/kg cRGD-ZW800-1 | Experimental | Drug: CRGD-ZW800-1n=3. Injection of 0.05 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery |
| 0.025 mg/kg cRGD-ZW800-1 | Experimental | Drug: CRGD-ZW800-1n=3. Injection of 0.025 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery |
| 0.01 mg/kg cRGD-ZW800-1 | Experimental | Drug: CRGD-ZW800-1n=3. Injection of 0.01 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery. |
| Expansion Cohort | Experimental | Drug: CRGD-ZW800-1n=18: expansion cohort will be added to the group of patients that had received the selected dose in WP-I. |
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 Laryngeal and hypopharyngeal cancer, eligible for surgical resection of the tumor by TLE;
- ≥ 18 years of age;
- Written informed consent must be obtained;
- Sufficient knowledge of the Dutch language to understand the informed consent form;
Key exclusion criteria (14 listed)
- History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent;
- Other synchronous biopsy proven malignancies currently active, except for adequately treated in situ carcinoma of cervix and basal, squamous cell skin carcinoma, or other head- and neck squamous cell cancer;
- Patients pregnant or breastfeeding;
- Patients with renal insufficiency (defined as eGFR < 60);
- Patients with previous kidney transplantation or a solitary functioning kidney;
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-ZW800-1Intravenous administration of study drug at lesat 2h prior to surgery | Drug | 0.01 mg/kg cRGD-ZW800-1, 0.025 mg/kg cRGD-ZW800-1, 0.05 mg/kg cRGD-ZW800-1, Expansion Cohort |
Primary outcome
WP-I: the optimal dose of cRGD-ZW800-1 for FLI of laryngeal and hypopharyngeal cancer
Time frame: Up to 48 hours after administration (Depending on pathology grossing)
Based on the tumor-to-background ratio (TBR) on breadloaves. Higher TBRs indicate a better outcome
WP-II: the rate of clear tumor resection margins
Time frame: Through histopathology, up to max 4 weeks post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Guided by Light trialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Uponr reasonable reasonable request
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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.
2 sites 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 Larynx and Squamous Cell Carcinoma of the Hypopharynx, run by Erasmus Medical Center at 2 sites 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 14 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: looking for participants now, 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 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
WP-I: the optimal dose of cRGD-ZW800-1 for FLI of laryngeal and hypopharyngeal cancer (time frame: Up to 48 hours after administration (Depending on pathology grossing)). 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.