Overview
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.
Description
Work package I:
In WP-I, the preferred dose of the agent for imaging of margins in oral cancer will be determined. The signal-to-noise ratio will be determined in dose group A (n=7), which will receive 0.05 mg/kg of the tracer, 16-20 hours before surgery. After an interim evaluation of this ratio, the second dose group B (n=7) will receive either a higher or a lower dosage (to be determined) of the tracer. After inclusion of all patients (n=14), the dose with the highest intraoperative signal-to-noise ratio will be selected.
Work package II:
In WP-II, an expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. In this group of 21 patients, it will be determined if FLI can improve the rate of adequate surgical resection margins. As secondary research questions, the following aspects will be assessed:
- sensitivity, specificity, positive and negative predictive values of FLI;
- colocalization with immunohistochemistry;
- change in surgical management; incremental operation time;
- FLI of excised cervical lymph nodes.
Eligibility
Inclusion Criteria:
- Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
- ≥ 18 years of age;
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations;
- 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:
- Previous surgery, chemotherapy or radiotherapy to the oral cavity;
- History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.
- Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
- Patients with renal insufficiency (eGFR<60);
- Patients with a previous kidney transplantation in the medical history;
- 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;
- Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.