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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center

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.