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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

283 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No