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

Conditions: pper urinary tract (ureters and pyela/renal pelvises) urothelial cell carcinoma for which blue light uretero-renoscopy and biopsies are performed for diagnosis.
MedDRA version: 9.1Level: LLTClassification code 10026431Term: Malignant neoplasm of renal pelvis and ureter transitional cell regional
MedDRA version: 9.1Level: LLTClassification code 10038497Term: Renal pelvis and ureter transitional cell cancer localized

Registration Number: EUCTR2007-005403-17-NL

Lead Sponsor: GE Healthcare

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

-. 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

Exclusion Criteria

-. 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to investigate the feasibility of Hexvix® blue light uretero-renoscopy ;Secondary Objective: -to compare the diagnostic value of Hexvix® blue light uretero-renoscopy with conventional<br>digital white light uretero-renoscopy<br>-to investigate the safety and toxicity of Hexvix® administered to the upper urinary tract<br>;Primary end point(s): The number of histology-confirmed malignant lesions found by blue light URS

Secondary Outcome Measures