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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00634621
Recruitment Status : Completed
First Posted : March 13, 2008
Results First Posted : August 25, 2014
Last Update Posted : August 25, 2014
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Bladder Cancer Drug: Hexaminolevulinate (Hexvix)

Study Design
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Study Type : Observational
Actual Enrollment : 283 participants
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.
Study Start Date : February 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Groups and Cohorts
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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.

Outcome Measures
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Primary Outcome Measures :
  1. 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®.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with documented or suspected bladder cancer.
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Spain
GE Healthcare
Madrid, Spain, 28108
Sponsors and Collaborators
GE Healthcare
Investigators
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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
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00634621    
Other Study ID Numbers: GEH-HEX-2007-01
First Posted: March 13, 2008    Key Record Dates
Results First Posted: August 25, 2014
Last Update Posted: August 25, 2014
Last Verified: August 2014
Keywords provided by GE Healthcare:
Bladder
Cancer
Cystoscopy
Hexaminolevulinate
Hexvix
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases