Clinical trial · Interventional
Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial
The STELLAR Trial: Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of the Hypopharynx | Hypopharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Larynx | Laryngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CRGD-ZW800-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 0.05 mg/kg cRGD-ZW800-1
- description
- n=3. Injection of 0.05 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery
- interventionNames
- Drug: CRGD-ZW800-1
- type
- EXPERIMENTAL
- label
- 0.025 mg/kg cRGD-ZW800-1
- description
- n=3. Injection of 0.025 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery
- interventionNames
- Drug: CRGD-ZW800-1
- type
- EXPERIMENTAL
- label
- 0.01 mg/kg cRGD-ZW800-1
- description
- n=3. Injection of 0.01 mg/kg cRGD-ZW800-1, within 2 hours before imaging/surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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; Exclusion Criteria: * 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; * 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;
References
Publications (0)
Data not yet available