An open-label, non-randomized, single center, single dose, exploratory phase II trial of FG001 (an imaging agent) in combination with transoral robotic surgery for oropharyngeal squamous cell carcinoma and neck dissection surgery for oral squamous cell carcinoma with regional lymph node metastases

Rigshospitalet1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2026年7月1日最近更新: 2026年6月8日

试验速览

OPSCC cohort: Evaluate the diagnostic performance of FG001

OSCC cohort: Evaluate the diagnostic performance of FG001

•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)

•Previous chemotherapy, major surgery, or radiotherapy to the oral cavity, pharynx or neck.
•Any known allergy or hypersensitivity to indocyanine green (ICG) or any other component of the IMP
•Female subjects who are pregnant or breast-feeding (pregnancy test positive prior to inclusion)
•Overall performance status or co-morbidity deeming the subject unfitted for participation in the trial as judged by the PI or a delegated investigator
•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.
•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.

发起方

申办方类型

Hospital/Clinic/Other health care facility

责任方

Principal Investigator

主要研究者

Andreas Kjær

Scientific

Rigshospitalet

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