Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer

Completed

• Conditions: Bladder Cancer

• Registration Number: NCT00634621
• Lead Sponsor: GE Healthcare

Brief Summary

The purpose of this study is to determine the effectiveness of hexaminolevulinate (Hexvix) in the diagnosis and treatment of patients with non-invasive bladder cancer and if it results in a change in patient management.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-26
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-13
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2014-07-09
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-12
• Last Update Submitted: 2014-08-12
• Results First Posted: 2014-08-25
• Last Update Posted: 2014-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 283

Inclusion Criteria

• Patients over 18 years of age.
• Patients of either sex.
• Patients with documented or highly suspected non-invasive bladder cancer.

Exclusion Criteria

• Patients with hypersensitivity to the drug substance or any excipient of Hexvix.
• Patients with porphyry.
• Women of childbearing age.
• Patients at a high risk of suffering extensive bladder inflammation e.g. patients after intravesical BCG treatment, patients with moderate or severe leukocyturia or patients undergoing recent bladder surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detecting the Rate of Bladder Cancer Lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) With Hexvix® in the Overall Study Population by Comparison With the Diagnostic Gold Standard, i.e. Histological Examination of Lesions Biopsy.	Day 0 (Post contrast administration)	Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®.

Secondary Outcome Measures

Name	Time	Method
Assess the Sensitivity of Standard White Light Cystoscopy (WLC) and Blue Light Cystoscopy (BLC) for Obtaining a Correct Diagnosis of Bladder Cancer at Individual Patient Level.	Day 0 (Post contrast administration)	The number of confirmed bladder cancer matches using cystoscopy compared to the diagnostic gold standard, i.e. histological examination of lesions biopsy.

Trial Locations

Locations (1)

GE Healthcare; 🇪🇸 Madrid, Spain