Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548438
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
The Impact of PDD During TURB for NMIBC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of PDD During TURB for NMIBC a Prospective Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TUR_BLUE
Brief Summary:
The goal of this clinical trial is to learn if photodynamic diagnosis PDD performed using violet light after intra-vesical instillation of hexaminolaevulinic acid Hexvix 85mg50ml is more sensitive than the standard white light tecnique in detection of malignant bladder tumour
Patients will be randomised to
Transurethral resection of the bladder TURB with a standard white light tecnique
TURB with the PDD tecnique using the study drug Hexvix
Patients will be randomised to
Transurethral resection of the bladder TURB with a standard white light tecnique
TURB with the PDD tecnique using the study drug Hexvix
Detailed Description:
Non-muscle invasive pT1 high-grade HG bladder cancer NIMBC represents a challenge for the urologists due to its aggressive behavior with a marked tendency to recur after transurethral resection of the bladder TURB and even progress to muscle-invasive disease To limit the risk of upstaging and to provide more clinical information indispensable for the decision-making process international guidelines strongly recommend a re-TURB to be performed within 2-6 weeks from the first resection in all pT1HG tumors However not all the published literature agrees on the value of re-TURB wich is also an invasive and morbid procedure requires a general or locoregional anesthesia and like all surgical procedure it is not free of risks and complications There is therefore an unmet need for improving the quality and completeness of TURB which may have an impact on the necessity of Re-TURB It has been confirmed that fluorescence-guided biopsy and resection photodynamic diagnosis-PDD are more sensitive than conventional procedures for the detection of malignant tumours particularly for CIS PDD is performed using violet light after intra-vesical instillation of hexaminolaevulinic acid Hexvix 85mg50mlTo date no randomized controlled trials RCTs have been conducted aiming to compare the completeness of TURB with PDD compared to TURB with standard white light WL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None