E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Urothelial tumors in the renal pelvis |
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E.1.1.1 | Medical condition in easily understood language |
The diagnostic ability of Gliolan on urothelial tumors in renal pelvis is evaluated |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038517 |
E.1.2 | Term | Renal pelvis cancer NOS |
E.1.2 | System Organ Class | 100000004864 |
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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 |
- Primary Objective: To evaluate the overall clinical effect of the method.
- Secondary Objective: To evaluate whether PDD guided uretero/nephroscopy is superior to standard white light diagnosis of UUTT.
-Tertiary Objective: To demonstrate that biopsies from the upper urinary tract system have proper quality for histological diagnosis.
-Quarterly Objective: To record adverse events to the study method used for diagnose and treatment of UUTT.
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E.2.2 | Secondary objectives of the trial |
The trial has no more objectives |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Low grade (WHO grade 1 or 2) tumours in the upper urinary tract.
-Patients with urothelial tumours and where RNU (radical nephroureterectomy) cannot be performed (due to one kidney, horseshoe shaped kidney, bilateral disease or co-morbidity which makes bigger surgery impossible)
-Tumour limited to renal pelvis and one calyx or limited to two calyxes
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E.4 | Principal exclusion criteria |
-Patients with porphyria
-Macroscopic haematuria, as it might interfere with the fluorescence guided cysto-ureteroscopy
-Known hypersensitivity to 5-ALA or porphyrins
-Pregnant or breast-feeding women (women of childbearing age will have a pregnancy test)
-Expected poor study compliance
-Patients < 18 years
-Patients who do not read or understand Danish
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E.5 End points |
E.5.1 | Primary end point(s) |
-Number of patients with tumours at 4 month follow up nephro-ureteroscopy after tumour clearance of the pelvis
-Number of patients who avoid RNU
-Overall diagnosis made by nephro-ureteroscopy
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Study will run for approximately 3 years |
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E.5.2 | Secondary end point(s) |
-Number of neoplastic lesions in the ureter and renal pelvis/calyces recorded by white light versus lesions recorded by PDD.
- Sensitivity and specificity of white light diagnosis and PDD.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
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 | No |
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.8.5 | The trial involves multiple Member States | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |