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

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

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.

Study Overview

• Status: Completed
• Conditions: Photodynamic Transurethral Resection of the Bladder (TUR-B)
• Intervention / Treatment: Drug: Hexvix

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Germany
  • Regensburg, Germany, 93059
    • Caritas-Krankenhaus St. Josef, Klinik fuer Urologie
  • Sindelfingen, Germany, 71065
    • Klinikverbund Südwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Bladder cancer patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

TUR-B; TUR-B in patients suspected to have non-muscle-invasive bladder cancer (NMIBC).

Drug: Hexvix; 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.; Other Names: hexyl aminolevulinate (HAL)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: November 28, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (ESTIMATE): December 16, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: A-94-58150-002