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

ConditionsSquamous Cell Carcinoma of the Larynx Squamous Cell Carcinoma of the Hypopharynx

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorErasmus Medical Center

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Sequential

Treatments tested in this trial

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

Treatment groups

27 Participants

are divided into 4 treatment groups

Group A: 0.05 mg/kg cRGD-ZW800-1Experimental treatment 1 intervention

Group B: 0.025 mg/kg cRGD-ZW800-1Experimental treatment 1 intervention

Group C: 0.01 mg/kg cRGD-ZW800-1Experimental treatment 1 intervention

Group D: Expansion CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Up to 48 hours after administration (Depending on pathology grossing)

WP-II: the rate of clear tumor resection margins

Time frame

Through histopathology, up to max 4 weeks post-op

Sponsors and contacts

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Erasmus Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: