Completed

NCT Number: NCT02012036

Study To Optimize Photodynamic Transurethral Resection of the Bladder (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.

Completed

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Key information

Conditions

Photodynamic Transurethral Resection of the Bladder (TUR-B)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: hexyl aminolevulinate (HAL)

Primary outcomes

Detection rate

Time frame: 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 outcomes

Detection rate for risk groups according to the European Organisation for Research and Treatment of Cancer (EORTC)-score

Time frame: 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

Time frame: At TUR-B visit, up to 1 year

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Acronym: OPTIC-III

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Dec 16, 2013
Registry last updated: Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.