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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.


N/A
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The primary objective of this study is to quantify the increase in sensitivity for detection of non-invasive bladder cancer with blue light fluorescence cystoscopy using hexaminolevulinate (Hexvix) as compared to standard white light cystoscopy.

Outcome Time Frame:

Since cystoscopy until pathology results are available.

Safety Issue:

No

Principal Investigator

Dr. Carlos Hernández

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gregorio Marañón Hospital, Madrid

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GEH-HEX-2007-01

NCT ID:

NCT00634621

Start Date:

February 2008

Completion Date:

September 2010

Related Keywords:

  • Bladder Cancer
  • Bladder
  • Cancer
  • Cystoscopy
  • Hexaminolevulinate
  • Hexvix
  • Urinary Bladder Neoplasms

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