N/A
Completed N=283
Effectiveness of Hexaminolevulinate (Hexvix) in the Diagnosis and Treatment of Patients With Non-invasive Bladder Cancer
Source: ClinicalTrials.gov NCT00634621 ↗Enrolled (actual)
283
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: 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. — 41; 1; 31; 30 Number of lesions
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
41; 1; 31; 30; 236; 2 | — |
| SECONDARY 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. |
86.3; 90.9 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00634621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.