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

Phase 1

• Conditions: rothelial tumors in the renal pelvis; MedDRA version: 17.0Level: LLTClassification code 10038517Term: Renal pelvis cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2014-000669-39-DK
• Lead Sponsor: Gregers Gautier Hermann

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-09
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - Primary Objective: To evaluate the overall clinical effect of the method.<br><br>- Secondary Objective: To evaluate whether PDD guided uretero/nephroscopy is superior to standard white light diagnosis of UUTT.<br><br>-Tertiary Objective: To demonstrate that biopsies from the upper urinary tract system have proper quality for histological diagnosis.<br><br>-Quarterly Objective: To record adverse events to the study method used for diagnose and treatment of UUTT.<br>;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<br><br>-Number of patients who avoid RNU<br><br>-Overall diagnosis made by nephro-ureteroscopy<br>;Timepoint(s) of evaluation of this end point: Study will run for approximately 3 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Number of neoplastic lesions in the ureter and renal pelvis/calyces recorded by white light versus lesions recorded by PDD.<br><br>- Sensitivity and specificity of white light diagnosis and PDD.<br>;Timepoint(s) of evaluation of this end point: after 3 years