Endoscopic treatment of neoplasia in the upper urinary tract and the value of fluorescence guided endoscopic follow up.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000669-39-DK

Enrollment

Registered

2014-04-09

Start date

2014-06-13

Completion date

Unknown

Last updated

2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial tumors in the renal pelvis MedDRA version: 17.0 Level: LLT Classification code 10038517 Term: Renal pelvis cancer NOS System Organ Class: 100000004864

Interventions

Trade Name: Gliolan Pharmaceutical Form: Granules and solvent for oral suspension INN or Proposed INN: 5-aminolevulinic acid hydrochloride CAS Number: 5451-09-2 Other descriptive name: AMINOLEVULINIC

Eligibility

Sex/Gender

All

Inclusion criteria

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 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: - 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. ;Secondary Objective: The trial has no more objectives;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 ;Timepoint(s) of evaluation of this end point: Study will run for approximately 3 years	—

Measure

Time frame

Main Objective: - 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. ;Secondary Objective: The trial has no more objectives;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 ;Timepoint(s) of evaluation of this end point: Study will run for approximately 3 years

—

Secondary

Measure	Time frame
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. ;Timepoint(s) of evaluation of this end point: after 3 years	—

Countries

Denmark

Contacts

Public Contactconsultant

Gregers G Hermann

gregers.gautier.hermann@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026