Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial
Trial statusRecruiting
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 volunteersQualifiers
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
DrugIntravenous administration of study drug at lesat 2h prior to surgery
Treatment groups
27 Participants
are divided into 4 treatment groupsGroup 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
1
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)2
WP-II: the rate of clear tumor resection margins
Time frame
Through histopathology, up to max 4 weeks post-opSponsors and contacts
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Source ClinicalTrials.gov