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

Ipsen

Status: Completed

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

Treatments: Drug: Hexvix

Study type: Observational

Funder types: Industry

Identifiers

NCT02012036

A-94-58150-002

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

400 participants in 1 patient group

TUR-B

Description:

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

Treatment:

Drug: Hexvix