Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

NCT00785694 | Withdrawn Phase 4

• 1 other identifier: GE-196-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of bladder cancer recurrence

  12 Months

Study Arms (2)

B

EXPERIMENTAL

One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix.

Drug: hexaminolevulinate

A

NO INTERVENTION

Multiple instillations of mitomycin C after transurethral resection in white light alone.

Interventions

hexaminolevulinate DRUG

Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.

Also known as: Hexvix

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

GE Healthcare Medical Diagnostics

Vélizy-Villacoublay, Morane Saulnier, 78457, France

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

5-aminolevulinic acid hexyl ester

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jean-Paul Antonini

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 5, 2008
• Study Start: December 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

FR (1)