Fluorescent Imaging Agent FG001 During Surgery for Mouth and Throat Cancer

Who can take part

• Naive subjects with either: Biopsy verified primary OPSCC, with or without regional metastases (T1–T2, N+/N−), scheduled for curative intended TORS OR OSCC and biopsy verified regional lymph node metastases (T1-T4, N+) scheduled for curative intended neck dissection surgery
• Location of tumor or neck metastases suitable for optical imaging
• Subjects aged 18 years or older
• Capable of understanding and giving written informed consent
• Subject must not previously have received the IMP
• Male subjects must commit to use barrier contraception (e.g., condom) during the trial and for 30 days after EoT and avoid sperm donation during this period
• Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 30 days after EoT. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilized or infertile, females must have undergone surgical sterilization (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea; may be confirmed with follicle-stimulating hormone [FSH] test if there is doubt)

Who cannot take part

• Previous chemotherapy, major surgery, or radiotherapy to the oral cavity, pharynx or neck
• Female subjects who are pregnant or breast-feeding (pregnancy test positive prior to inclusion)
• Any known allergy or hypersensitivity to indocyanine green (ICG) or any other component of the IMP
• Pre-existing hepatic (Aspartate transaminase (AST) and/or alanine transaminase (ALT) >3 times the upper limit of normal; or Total bilirubin >1.5 times the upper limit of normal unless the elevation is attributable to Gilbert’s syndrome) and/or renal insufficiency (Estimated GFR (eGFR) < 45 ml/min/1.73m2)
• Abnormal coagulation profile with any of the following: Platelets < 100 ×10^9/L (equivalent to <100,000/µL) and/or aPTT >1.5x upper limit of normal and/or INR >1.71. NOTE: If a subject is being treated with anticoagulants and the INR is borderline (approximately 1.8) and the PI judges the subject to be eligible with no safety concerns, such subject may be deemed eligible for the trial
• Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the PI or a delegated investigator