E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Upper urinary tract (ureters and pyela/renal pelvises) urothelial cell carcinoma for which blue light uretero-renoscopy and biopsies are performed for diagnosis. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10026431 |
E.1.2 | Term | Malignant neoplasm of renal pelvis and ureter transitional cell regional |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038497 |
E.1.2 | Term | Renal pelvis and ureter transitional cell cancer localized |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to investigate the feasibility of Hexvix® blue light uretero-renoscopy |
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E.2.2 | Secondary objectives of the trial |
-to compare the diagnostic value of Hexvix® blue light uretero-renoscopy with conventional digital white light uretero-renoscopy -to investigate the safety and toxicity of Hexvix® administered to the upper urinary tract
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
The number of histology-confirmed malignant lesions found by blue light URS |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
blue light uretero-renoscopy with hexvix is compared to white light uretro-renoscopy (no Hexvix) |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is when the last patient has undergone uretero-renoscopy |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |