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

NCT02012036 | Completed

• 1 other identifier: A-94-58150-002
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Photodynamic Transurethral Resection of the Bladder (TUR-B)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Evaluation of the diagnostic procedure in practice and compared to procedures according to published recommendations

  At TUR-B visit, up to 1 year

Study Arms (1)

TUR-B

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

Drug: Hexvix

Interventions

Hexvix DRUG

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.

Also known as: hexyl aminolevulinate (HAL)

TUR-B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bladder cancer patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (2)

Caritas-Krankenhaus St. Josef, Klinik fuer Urologie

Regensburg, 93059, Germany

Location

Klinikverbund Südwest

Sindelfingen, 71065, Germany

Location

MeSH Terms

Interventions

5-aminolevulinic acid hexyl ester

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 16, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

DE (2)