Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

Bladder Cancer Clinical Trial

Official title:

Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00785694
• Other study ID #: GE-196-001
• Status: Withdrawn
• Phase: Phase 4
• First received: November 4, 2008
• Last updated: April 23, 2015
• Start date: December 2008
• Est. completion date: August 2011

Study information

• Verified date: April 2015
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• hexaminolevulinate
Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.

Locations

Country	Name	City	State
France	GE Healthcare Medical Diagnostics	Velizy Cedex	Morane Saulnier

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of bladder cancer recurrence		12 Months	No