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

Sponsor

Ipsen (Industry)

Overall Status

Completed

CT.gov ID

NCT02012036

Collaborator

(none)

400

Enrollment

Locations

Duration (Months)

200

Patients Per Site

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Photodynamic Transurethral Resection of the Bladder (TUR-B)	Drug: Hexvix

Study Design

Study Type:

Observational

Actual Enrollment :

400 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

Detection rate [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 Outcome Measures

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]
Risk groups are low, intermediate and high.
Evaluation of the diagnostic procedure in practice and compared to procedures according to published recommendations [At TUR-B visit, up to 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Caritas-Krankenhaus St. Josef, Klinik fuer Urologie	Regensburg		Germany	93059
2	Klinikverbund Südwest	Sindelfingen		Germany	71065

Sponsors and Collaborators

Ipsen

Investigators

Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ipsen

ClinicalTrials.gov Identifier:

NCT02012036

Other Study ID Numbers:

A-94-58150-002

First Posted:

Dec 16, 2013

Last Update Posted:

Aug 16, 2019

Last Verified:

Aug 1, 2019

Additional relevant MeSH terms:

Aminolevulinic Acid

Study Results

No Results Posted as of Aug 16, 2019