Study To Optimize Photodynamic Transurethral Resection of the Bladder (TUR-B) In Clinical Practice

Completed

• Conditions: Photodynamic Transurethral Resection of the Bladder (TUR-B)
• Interventions: Drug: Hexvix

• Registration Number: NCT02012036
• Lead Sponsor: Ipsen

Brief Summary

The purpose of the study is to assess additional detection of Non-Muscle-Invasive Bladder Cancer (NMIBC) with hexyl aminolevulinate (HAL) cystoscopy based on lesions in patients undergoing TUR-B compared to white-light cystoscopy under the conditions of daily clinical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-11-28
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-16
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Indication of TURB due to suspicion of NMIBC (patients suspected to have non muscle invasive bladder cancer).
• Subject able to comply with the protocol.
• Written informed consent available.

Exclusion Criteria

• Hypersensitivity to the active substance or to any of the excipients of the solvent.
• Porphyria.
• Gross haematuria.
• Women of child-bearing potential.
• Repeated TURB (control TURB) as part of follow-up after previous TURB.
• Bacillus Calmette-Guerin (BCG) or Mitomycin / intravesical chemotherapy instillation therapy in the last 12 weeks or any other contraindications according to the SmPC.
• Subjects not able to give informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TUR-B	Hexvix	TUR-B in patients suspected to have non-muscle-invasive bladder cancer (NMIBC).

Primary Outcome Measures

Name	Time	Method
Detection rate	At TUR-B visit, up to 1 year	Detection rate is defined as number of lesions detected or not (Detection by HAL cystoscopy compared to white light cystoscopy confirmed by histology).

Secondary Outcome Measures

Name	Time	Method
Detection rate for risk groups according to the European Organisation for Research and Treatment of Cancer (EORTC)-score	At TUR-B visit, up to 1 year	Risk groups are low, intermediate and high.
Evaluation of the diagnostic procedure in practice and compared to procedures according to published recommendations	At TUR-B visit, up to 1 year

Trial Locations

Locations (2)

Caritas-Krankenhaus St. Josef, Klinik fuer Urologie; 🇩🇪 Regensburg, Germany

Klinikverbund Südwest; 🇩🇪 Sindelfingen, Germany