Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT00634621|
Recruitment Status : Completed
First Posted : March 13, 2008
Results First Posted : August 25, 2014
Last Update Posted : August 25, 2014
|Condition or disease||Intervention/treatment|
|Bladder Cancer||Drug: Hexaminolevulinate (Hexvix)|
|Study Type :||Observational|
|Actual Enrollment :||283 participants|
|Official Title:||A Post-authorization, Observational Study to Assess the Impact of Blue Light Cystoscopy After Administration of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer.|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
- Drug: Hexaminolevulinate (Hexvix)
Each patient enrolled into the study will be infused with 50 mL of a 2 mg/mL Hexvix solution in the bladder using a catheter. Subsequently, after fluid retention by the patient in the bladder for one hour, the bladder will be emptied.
- 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. [ Time Frame: Day 0 (Post contrast administration) ]Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®.
- 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. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00634621
|Madrid, Spain, 28108|
|Principal Investigator:||Dr. Carlos Hernández||Gregorio Marañón Hospital, Madrid|
|Principal Investigator:||Dr. Eduardo Solsona||Valencian Institute of Oncology, Valencia|
|Principal Investigator:||Dr. Joan Palou||Fundación Puigvert, Barcelona|