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: December 5, 2013
Last verified: December 2013

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:
  • 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. [ Time Frame: Since cystoscopy until pathology results are available. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To ascertain whether use of hexaminolevulinate (Hexvix) for diagnosis of non-invasive bladder cancer results in a change in patient management. [ Time Frame: At the end of study. ] [ Designated as safety issue: No ]
  • To assess the safety profile of Hexvix in daily clinical practice. [ Time Frame: Between the administration of Hexvix and 72 hours following this administration. ] [ Designated as safety issue: Yes ]

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 instilled 50 mL of a 8 mmol/L 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.
  Contacts and Locations
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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

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
Last Updated: December 5, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by GE Healthcare:

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

ClinicalTrials.gov processed this record on August 20, 2014