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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This study has been withdrawn prior to enrollment.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)
Information provided by (Responsible Party):
GE Healthcare Identifier:
First received: November 4, 2008
Last updated: April 23, 2015
Last verified: April 2015
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: 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00785694

GE Healthcare Medical Diagnostics
Velizy Cedex, Morane Saulnier, France, 78457
Sponsors and Collaborators
GE Healthcare
Study Director: Jean-Paul Antonini GE Healthcare
  More Information

Responsible Party: GE Healthcare Identifier: NCT00785694     History of Changes
Other Study ID Numbers: GE-196-001
Study First Received: November 4, 2008
Last Updated: April 23, 2015

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes processed this record on May 23, 2017