Comparison of Fluorescein-INtra-VItal microscopy Versus conventional frozen section diagnosis for intraOperative histopathological evaluation - INVIVO

Technische Universität München, Fakultät für Medizin0 个研究点目标入组 200 人开始时间: 2020年3月6日最近更新: 2021年5月17日

试验速览

暂无简介。

•1.Age =18 years
•2.Signed informed consent
•3.Suspected intracranial tumor revealed by cranial magnetic resonance imaging (according to clinical routine) scheduled for resection with intraoperative frozen section Evaluation
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 190
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1.Known allergic or suspected allergic reactions to fluorescein sodium
•2.Liver disease, CHILD B or C
•3.Patients under medication with beta-blockers, digoxin, chinidin and probenecid as well as inhibitors of glucuronidation, such as immunosuppressants, when the medication must not be discontinued perioperatively
•4. Patients with relevant congenital limitations of glucoronidation performance (e.g. Rotor syndrome, Gilbert-Meulengracht syndrome, Crigler-Najjar syndrome)
•5.Patients with terminal renal failure requiring hemodialysis
•6.Inability to provide informed consent
•7.Pregnancy (incl. positive pregnancy test)
•8.Women of childbearing age must be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test. Acceptable methods of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correct are such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner.

发起方

Technische Universität München, Fakultät für Medizin