CRGD-ZW800-1 for Oral cancer|Squamous cell carcinoma of the oral cavity

Inclusion criteria

• {"criterion_text":"- Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;\n- Patients ≥ 18 years of age;\n- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations."}

Exclusion criteria

• {"criterion_text":"- Previous surgery, chemotherapy or radiotherapy to the oral cavity;\n- History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.\n- Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;\n- Patients with renal insufficiency (eGFR<60);\n- Patients with a previous kidney transplantation in the medical history;\n- Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2 inhibitors);\n- 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;\n- Any condition that the investigator, anesthesiologist or head- and neck surgeon considers to be potentially jeopardizing the patient's wellbeing or the study objectives."}

Primary endpoints

• {"endpoint_text":"- Rate of adequate (i.e. >5mm clear) tumor resection margins.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Sensitivity, specificity, positive and negative predictive values","definition_or_measurement_approach":""}
• {"endpoint_text":"- Co-localization of FLI with immunohistochemistry on pathology slides","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percentage of extra tissue resection based on FLI-driven frozen sections","definition_or_measurement_approach":""}
• {"endpoint_text":"- Operation time","definition_or_measurement_approach":""}
• {"endpoint_text":"- FLI of lymph node metastases after neck dissection","definition_or_measurement_approach":""}

Netherlands

Earliest CTIS Part Ii Submission Date

10-12-2024

Latest Decision Or Authorization Date

17-12-2024

Processing Time Days

7

Number Of Sites

1

Number Of Participants

31

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands