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.
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.
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);
Sequential
cRGD-ZW800-1.
DrugInjection of cRGD-ZW800-1 within 48 hours before imaging/surgery
WP-I: (Highest) mean tumor-to-background ratio (TBR)
Two dosages of cRGD-ZW800-1 are tested in two groups of each 7 patients. An expansion cohort (n=14) will be added to the dose group that yields the highest TBR.
WP-II: Rate of adequate (i.e. >5mm clear) tumor resection margins.
WP-II: Sensitivity, specificity, positive and negative predictive values
WP-II: Co-localization of FLI with immunohistochemistry on pathology slides
WP-II: Percentage of extra tissue resection based on FLI-driven frozen sections
WP-II: Operation time
Click on the lead sponsor to view all of their trials.
