Image guided surgery in sinonasal inverted papilloma by targeting vascular endothelial growth factor - SNIPER

niversitair Medisch Centrum Groningen0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•- Biopsy confirmed diagnosis of SNIP and scheduled to undergo surgical resection as decided by the Multi-Disciplinary Head and Neck Tumor Board of the UMCG;
•- Age * 18 years;
•- Written informed consent;
•- Mentally competent person that is able and willing to comply with study procedures;
•- Acceptable hematologic status, kidney function and liver function, as standard surgery protocol requires.

•- Medical or psychiatric conditions that compromise the patient*s ability to give informed consent;
•- Concurrent uncontrolled medical conditions;
•- Received an investigational drug within 30 days prior to the dose of the fluorescent tracer;
•- Tumors at sites of which the surgeon would assess that in vivo imaging would not be feasible;
•- History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease or unstable angina within 6 months prior to enrollment;
•- Inadequately controlled hypertension with or without current antihypertensive medications;
•- History of infusion reactions to bevacizumab or other monoclonal antibody therapies;
•- Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. Woman of childbearing potential are premenopausal women with intact reproductive organs and women less than two years after menopause;
•- Lab values that in the opinion of the primary surgeon would prevent surgical resection;
•- Life expectancy < 12 weeks;

发起方