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

Launched by ERASMUS MEDICAL CENTER · Feb 21, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new method called fluorescence imaging (FLI) to help surgeons during surgery for laryngeal and hypopharyngeal cancer, specifically a type called squamous cell carcinoma. The main goals are to see if this imaging technique can help doctors find and remove all of the cancer during surgery, and to determine the best dose of a special imaging agent used in the process. The trial will involve two parts: one will focus on how well FLI works during surgery, while the other will check if it can reduce the chances of leaving cancer behind.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of squamous cell cancer in the larynx or hypopharynx that requires surgical removal. They should also be able to read and understand the information provided in Dutch. Unfortunately, some individuals may not qualify if they have certain medical conditions, like severe allergies or kidney issues, or if they are pregnant or breastfeeding. Participants can expect to undergo surgery with this new imaging technique and will be closely monitored for any effects. This trial is currently not recruiting participants, but it aims to improve cancer surgery outcomes in the future.

Gender

ALL

Eligibility criteria

• 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;