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Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

Phase 4
18 Years
Not Enrolling
Bladder Cancer

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Trial Information

Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Rate of bladder cancer recurrence

Outcome Time Frame:

12 Months

Safety Issue:


Principal Investigator

Jean-Paul Antonini

Investigator Role:

Study Director

Investigator Affiliation:

GE Healthcare


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

December 2008

Completion Date:

August 2011

Related Keywords:

  • Bladder Cancer
  • Urinary Bladder Neoplasms
  • Recurrence