Recurrence of Bladder Cancer After Transurethral Resection With Hexvix - Full Text View

Sponsored by:	GE Healthcare
Information provided by:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00785694

Purpose

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).

Condition	Intervention	Phase
Bladder Cancer	Drug: hexaminolevulinate	Phase IV

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Hexyl 5-aminolevulinate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

Further study details as provided by GE Healthcare:

Primary Outcome Measures:

Rate of bladder cancer recurrence [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	260
Study Start Date:	December 2008
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Experimental One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.	Drug: hexaminolevulinate Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.
A: No Intervention Multiple instillations of mitomycin C after transurethral resection in white light alone.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785694

Locations

France, Morane Saulnier
GE Healthcare Medical Diagnostics
Velizy Cedex, Morane Saulnier, France, 78457

Sponsors and Collaborators

GE Healthcare

Investigators

Study Director:

Jean-Paul Antonini

GE Healthcare

More Information

Responsible Party:	Radboud University Medical Center, Dpt Urology ( Fred Witjes, M.D. )
Study ID Numbers:	GE-196-001
Study First Received:	November 4, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00785694
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Holland: Centrale Commissie Mensgebonden Onderzoek

Study placed in the following topic categories:

Cystocele
Urologic Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms

Urologic Neoplasms
Urinary tract neoplasm
Recurrence
Bladder neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009