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

Sponsor:	GE Healthcare
Information provided by:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00634621

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:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Hexyl 5-aminolevulinate

U.S. FDA Resources

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 ]

Estimated Enrollment:	300
Study Start Date:	February 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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

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:	Emilio Moreno/Medical Director Region 4, 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:	April 29, 2010
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by GE Healthcare:

Bladder
Cancer
Cystoscopy
Hexaminolevulinate
Hexvix

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012