cancer squamous cell carcinoma of the oral cavity
Conditions
Interventions
Injection of cRGD-ZW800-1 within 48 hours before imaging/surgery
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor; 2. Patients >= 18 years of age; 3. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) To determine the TBR of cRGD-ZW800-1 in patients with oral cancer; 2) To determine if using FLI can increase the rate of adequate (i.e. >5mm clear) tumor resection margins. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To determine the recommended dosage of cRGD-ZW800-1 for intraoperative imaging of oral cancer. 2) To determine the sensitivity, specificity, positive and negative predictive values of FLI 3) To-determine colocalization of FLI with immunochemistry on pathology slides 4) To determine the percentage of extra tissue resection based on FLI-driven frozen sections 5) To determine if FLI significantly increases operation time 6) To determine if lymph node metastases can be identified using FLI | — |
Countries
Netherlands
Outcome results
None listed