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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00634621
First received: February 26, 2008
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.
  Eligibility

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634621

Locations
Spain
GE Healthcare
Madrid, Spain, 28108
Sponsors and Collaborators
GE Healthcare
Investigators
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

No publications provided

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:
Bladder
Cancer
Cystoscopy
Hexaminolevulinate
Hexvix

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
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 November 24, 2014