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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00785694
First Posted: November 5, 2008
Last Update Posted: April 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GE Healthcare
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Enrollment: 0
Study Start Date: December 2008
Study Completion Date: August 2011
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00785694     History of Changes
Other Study ID Numbers: GE-196-001
First Submitted: November 4, 2008
First Posted: November 5, 2008
Last Update Posted: April 24, 2015
Last Verified: April 2015

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