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

NCT05752149 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NL74742.078.21
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Squamous Cell Carcinoma of the Larynx; Squamous Cell Carcinoma of the Hypopharynx

Keywords

Tumour specific fluorescence imaging

Outcome Measures

Primary Outcomes (2)

• 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)

• WP-II: the rate of clear tumor resection margins

  Through histopathology, up to max 4 weeks post-op

Study Arms (4)

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

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

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.

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.

Drug: CRGD-ZW800-1

Interventions

CRGD-ZW800-1 DRUG

Intravenous administration of study drug at lesat 2h prior to surgery

0.01 mg/kg cRGD-ZW800-1; 0.025 mg/kg cRGD-ZW800-1; 0.05 mg/kg cRGD-ZW800-1; Expansion Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location

Related Links

• Guided by Light trial

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The pathologist will be initially blinded during intraoperative assessment of the fresh surgical specimen.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Otorhinolaryngologist, Head and Neck Surgeon, MD, PhD

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 2, 2023
• Study Start: June 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

NL (1)