EUCTR2007-005403-17-NL进行中（未招募）不适用
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 - Blue light uretero-renoscopy detecting upper tract urothelial cell carcinoma
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-. Patients with known UCC of the 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 (see appendix 1)
- •-. 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
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-. 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 uretro-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
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