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

Study Overview
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Brief Summary
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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.

Official Title
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OPTIC-III Prospective Non-Interventional Study To Optimize Photodynamic TUR-B In Clinical Practice

Conditions
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Photodynamic Transurethral Resection of the Bladder (TUR-B)

Intervention / Treatment
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* Drug: Hexvix


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TUR-B<br>TUR-B in patients suspected to have non-muscle-invasive bladder cancer (NMIBC). | Drug: Hexvix<br>* As this is a non-interventional study, detection of NMIBC with Hexvix is in a pre-defined group, chosen prior to and independently from the decision to enrol the subject in this study. The detection with Hexvix should be in accordance with local Summary of Product Characteristics [SmPC]. Subjects will be treated in accordance with usual medical practice during their participation in this study, no additional assessment or tests will be required.<br>* Other names: hexyl aminolevulinate (HAL);|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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