Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial

Squamous Cell Carcinoma of the Larynx Clinical Trial

— STELLAR  

Official title:

The STELLAR Trial: Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05752149
• Other study ID #: NL74742.078.21
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: November 2025

Study information

• Verified date: February 2024
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Work package II (WP-II) is designed to assess whether FLI can detect and decrease tumor positive margins after a TLE.

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;

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 27
• Est. completion date: November 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Hypopharyngeal Neoplasms
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Hypopharynx
• Squamous Cell Carcinoma of the Larynx

Intervention

Drug:
• CRGD-ZW800-1
Intravenous administration of study drug at lesat 2h prior to surgery

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 48 hours after administration (Depending on pathology grossing)
Primary	WP-II: the rate of clear tumor resection margins		Through histopathology, up to max 4 weeks post-op

External Links

•   Guided by Light trial