A prospective, comparative single center study of Hexvix® fluorescence uretero-renoscopy and white light uretero-renoscopy in the detection of upper urinary tract urothelial cell carcinoma - White and blue light uretero-renoscopy for the upper urinary tract

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

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•-Patients with known urothelial cell carcinoma (UCC) of the upper urinary tract (UUT)
•-Patients with suspicion for UCC of the UUT based on one of the following:
•-unilateral or bilateral ureter sampling (suspect or malignant cells on cytology)
•-suspect or malignant cells on urine cytology, with negative bladder biopsies
•-macroscopic tumor on previous uretero-renoscopy
•-tumor seen on imaging techniques (ultrasound, IVP, CT, MRI)
•-Patients with ZUBROD-ECOG-WHO performance status of 0-2
•-Patients must be over 18 years of age
•-Patients must be fully informed of the investigational nature of the study and signed written informed consent must be obtained prior to any study specific investigations

•-Patients with existing or recurrent severe urinary tract infection
•-Gross haematuria (defined as heavy bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence uretero-renoscopy. Where the bleed is light, the patient should not be excluded if in the investigator*s opinion rinsing during uretero-renoscopy will alleviate the possible interference with fluorescence cystoscopy)
•-Patients with porphyria
•-Known allergy to hexyl aminolevulinate hydrochloride or a similar compound
•-Pregnant or breast-feeding (patients must use adequate birth control methods while on the study and for 4 weeks following the end of treatment)
•-Patients who have received BCG or chemotherapy in the UUT within 3 months prior to uretero-renoscopy
•-Conditions associated with a risk of poor protocol compliance

发起方

niversitair Medisch Centrum Sint Radboud