Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

GE Healthcare1 site in 1 countryDecember 2008

ConditionsBladder Cancer

Interventionshexaminolevulinate

Drugshexaminolevulinate

Overview

Phase: Phase 4
Intervention: hexaminolevulinate
Conditions: Bladder Cancer
Sponsor: GE Healthcare
Locations: 1
Primary Endpoint: Rate of bladder cancer recurrence
Status: Withdrawn
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomised, comparative, multicentre study to determine if the early recurrence rate of intermediate-risk bladder cancer is similar in subjects treated with multiple instillations of mitomycin C after resection conducted under white light cystoscopy (group A) and subjects treated with 1 instillation of mitomycin C after resection conducted under white light and blue light cystoscopy (group B).

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

August 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GE Healthcare

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subject is not of childbearing potential and signed informed consent.
•Subject with 1 or more primary bladder tumours, confirmed on an outpatient cystoscopy or subjects with 1 or more recurrent bladder tumours appearing within 12 months of removal of a previous bladder tumour, confirmed on an outpatient cystoscopy.

Exclusion Criteria

•The subject was previously included in this study.
•The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS).
•The subject is suspected to have single primary or single recurrent TaG1 tumours when recurrence occurs more than 1 year after initial diagnosis or previous recurrence.
•The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract.
•The subject has gross haematuria.
•The subject has a history of porphyria.