Guided by light: Optimizing surgical excision of oral cancer using real-time fluorescence imaging

Erasmus University Medical Center0 个研究点目标入组 29 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•1) Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
•2) = 18 years of age;
•3) Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
•4) 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;
•5) The patient has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening;
•6) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

•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) Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives.

发起方