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Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

This study has been withdrawn prior to enrollment.
(Rejected ethics approval in UK and Holland)
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00785694
First received: November 4, 2008
Last updated: February 4, 2010
Last verified: February 2010
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: B
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.
Other Name: Hexvix
No Intervention: A
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
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

No publications provided

Responsible Party: Fred Witjes, M.D., Radboud University Medical Center, Dpt Urology
ClinicalTrials.gov Identifier: NCT00785694     History of Changes
Other Study ID Numbers: GE-196-001
Study First Received: November 4, 2008
Last Updated: February 4, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Holland: Centrale Commissie Mensgebonden Onderzoek

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Recurrence
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013