Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer

Launched by ERASMUS MEDICAL CENTER · Dec 5, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new technique called fluorescence-guided surgery to help doctors see and remove oral cancer more effectively. Specifically, the researchers are looking at a special imaging agent called cRGD-ZW800-1, which helps highlight tumor areas during surgery. The goal is to ensure that all cancerous tissue is removed, which is crucial for better treatment outcomes.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of squamous cell carcinoma of the oral cavity, meaning they have a specific type of mouth cancer that can be surgically treated. Patients who have had previous treatments like surgery, chemotherapy, or radiation in the mouth area will not be eligible. If chosen to participate, patients can expect to undergo surgery where this new imaging technique will be used, and they’ll be monitored closely for their health and any side effects. This study is currently recruiting participants of all genders, and it's important for potential participants to understand the safety measures in place to protect their well-being throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
• • 2. ≥ 18 years of age;
• • 3. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations;
• • 4. Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant.
• Exclusion Criteria:
• • 1. Previous surgery, chemotherapy or radiotherapy to the oral cavity;
• • 2. History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.
• • 3. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
• • 4. Patients with renal insufficiency (eGFR\<60);
• • 5. Patients with a previous kidney transplantation in the medical history;
• • 6. Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired on weakened immune system, caused by either a pre-existing disease or concomitant medications;
• • 7. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.