pyelum tumors ureter tumors
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -The number of patients with histology-confirmed tumors found by blue light URS | — |
Secondary
| Measure | Time frame |
|---|---|
| All lesions must be histologically confirmed: -The proportion of patients with tumor(s) found by blue light URS, but not on white light (fiberoptic or digital) URS -The proportion of patients with tumor(s) found by white light (fiberoptic or digital) URS, but not on blue light URS -The proportion of false-positive lesions on blue light URS and white light (fiberoptic or digital) URS -The detection rate of white light (fiberoptic or digital) URS combined with blue light URS for patients with tumor(s). -Registration of adverse events | — |
Countries
Netherlands
Outcome results
None listed