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

Conditions: pyelum tumors
ureter tumors
10038364
10038365

Registration Number: NL-OMON32388

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

-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

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 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-The number of patients with histology-confirmed tumors found by blue light URS</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>All lesions must be histologically confirmed:<br /><br>-The proportion of patients with tumor(s) found by blue light URS, but not on<br /><br>white light (fiberoptic or digital) URS<br /><br>-The proportion of patients with tumor(s) found by white light (fiberoptic or<br /><br>digital) URS, but not on blue light URS<br /><br>-The proportion of false-positive lesions on blue light URS and white light<br /><br>(fiberoptic or digital) URS<br /><br>-The detection rate of white light (fiberoptic or digital) URS combined with<br /><br>blue light URS for patients with tumor(s).<br /><br><br /><br>-Registration of adverse events</p><br>