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

This study has been completed.
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
First received: February 26, 2008
Last updated: August 12, 2014
Last verified: August 2014
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.

Condition Intervention
Bladder Cancer
Drug: Hexaminolevulinate (Hexvix)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Resource links provided by NLM:

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Detecting the number of bladder cancer lesions by White-Light Cystoscopy (WLC) and Blue-Light Cystoscopy (BLC) with Hexvix®.

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    The number of confirmed bladder cancer matches using cystoscopy compared to the diagnostic gold standard, i.e. histological examination of lesions biopsy.

Enrollment: 283
Study Start Date: February 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with documented or suspected 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00634621

GE Healthcare
Madrid, Spain, 28108
Sponsors and Collaborators
GE Healthcare
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
  More Information

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00634621     History of Changes
Other Study ID Numbers: GEH-HEX-2007-01 
Study First Received: February 26, 2008
Results First Received: July 9, 2014
Last Updated: August 12, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by GE Healthcare:

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Aminolevulinic Acid
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 01, 2016