Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

General Electric (GE)

Status and phase

Withdrawn

Phase 4

Conditions

Bladder Cancer

Treatments

Drug: hexaminolevulinate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00785694

GE-196-001

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.