Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial
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
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
Treatments tested in this trial
- CRGD-ZW800-1
Treatment groups
27 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov