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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014