Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
NCT ID: NCT00233402
Last Updated: 2013-10-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
789 participants
INTERVENTIONAL
2005-01-31
2008-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A better detection of papillary bladder cancer and early detection of CIS lesions will provide the patient with a more complete TURB, a more optimal pharmacological treatment when needed, may reduce the need for follow up cystoscopies and hopefully result in a better prognosis for the patient.
The aim of the present study is to compare Hexvix cystoscopy with white light cystoscopy in the detection of histology confirmed papillary bladder cancer in patients with papillary bladder cancer and to compare early recurrence rate after Hexvix and white light transurethral resection (TURB) with white light TURB in patients with superficial bladder cancer.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard White Light Cystoscopy
Standard white light cystoscopy
Standard White Light and Hexvix Fluorescence Cystoscopy
Hexvix
Single Instillation, Transurethral Resection of the Bladder
Standard white light cystoscopy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hexvix
Single Instillation, Transurethral Resection of the Bladder
Standard white light cystoscopy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with more than one initial bladder tumor confirmed on an outpatient cystoscopy.
* Patients having recurrence within 12 months confirmed on an outpatient cystoscopy
* Patients with more than one papillary lesion at recurrence independently of the time of the recurrence confirmed on an outpatient cystoscopy
Exclusion Criteria
* Gross hematuria. (Note: Gross hematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy).
* Patient with porphyria.
* Known allergy to hexyl aminolevulinate hydrochloride or a similar compound.
* Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
* Pregnant or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and use the contraceptive pill or intrauterine device (IUD) during the treatments and for at least one month thereafter).
* Patients who have received BCG or chemotherapy within three months prior to the initial cystoscopy/TURB, except for a single dose of chemotherapy for prevention of seeding after resection.
* Conditions associated with a risk of poor protocol compliance.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Photocure
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
H Barton Grossman
Role: PRINCIPAL_INVESTIGATOR
The University of Texas, MD Anderson Cancer Center, Department of Urology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford Cancer Center, Department of Urology
Stanford, California, United States
V.A. Medical Center
Gainesville, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
South Florida Clinical Research Center, Inc.
Pembroke Pines, Florida, United States
The Emory Clinic, Dept of Urology
Atlanta, Georgia, United States
Boston University School of Medicine
Boston, Massachusetts, United States
St. Joseph Mercy Hospital- Ann Arbor
Ann Arbor, Michigan, United States
Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mount Sinai Medical Center, Department of Urology
New York, New York, United States
URMC
Rochester, New York, United States
Urological Institute at Beachwood Cleveland Clinic
Beachwood, Ohio, United States
Thomas Jefferson Medical College, Department of Neurology
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center, Department of Urologic Surgery
Nashville, Tennessee, United States
Baylor College of Medicine, Scott Department of Urology
Houston, Texas, United States
AKH, Klinik für Urologie der Universität Wien
Vienna, , Austria
Kingston General Hospital
Kingston, Ontario, Canada
CHUQ Hotel-Dieu de Quebec
Québec, , Canada
University Clinic of Giessen, Department of Urology
Giessen, , Germany
Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik
München, , Germany
Urologische Klinik München-Planegg
Planegg, , Germany
Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie
Regensburg, , Germany
Universitätsklinik Tuebingen, Universitätsklinik für Urologie
Tübingen, , Germany
Department of Urology, Academic Medical Center, University of Amsterdam
Amsterdam, , Netherlands
Department of Urology, UMC St. Radboud
Nijmegen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Stenzl A, Burger M, Fradet Y, Mynderse LA, Soloway MS, Witjes JA, Kriegmair M, Karl A, Shen Y, Grossman HB. Hexaminolevulinate guided fluorescence cystoscopy reduces recurrence in patients with nonmuscle invasive bladder cancer. J Urol. 2010 Nov;184(5):1907-13. doi: 10.1016/j.juro.2010.06.148. Epub 2010 Sep 17.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PC B305/02
Identifier Type: -
Identifier Source: org_study_id
NCT00209157
Identifier Type: -
Identifier Source: nct_alias