Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy
A Randomized, Comparative, Controlled Phase III, Multicenter Study of Hexvix Fluorescence Cystoscopy and White Light Cystoscopy in the Detection Of Papillary Bladder Cancer and the Early Recurrence Rate in Patients With Bladder Cancer
1 other identifier
interventional
789
5 countries
25
Brief Summary
The purpose of this study is to document the additional detection of papillary bladder cancer and the reduced early recurrence due to the improved detection and resection of these tumors after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary bladder cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2005
Typical duration for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 4, 2005
CompletedFirst Posted
Study publicly available on registry
October 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
October 11, 2013
CompletedOctober 11, 2013
August 1, 2013
3.5 years
October 4, 2005
August 5, 2013
August 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of Patients With >= 1 Ta or T1 Tumor Detected With Blue Light and Not White Light
Day 0
Comparison of the Proportions of Patients in the White Light Cystoscopy and Hexvix Groups Who Underwent TURB for a Histologically-confirmed Ta or T1 Tumor Who Had a Recurrence ( CIS, Ta, T1 or T2-T4 Tumor) Within 9 Months.
9 months
Secondary Outcomes (2)
Proportion of False Positive Lesions of Hexvix Cystoscopy and White Light Cystoscopy.
Day 0
Proportion of Patients With at Least One CIS Lesion Detected With Blue Light and None Seen With White Light.
Day 0
Study Arms (2)
Standard White Light Cystoscopy
ACTIVE COMPARATORStandard White Light and Hexvix Fluorescence Cystoscopy
EXPERIMENTALInterventions
Single Instillation, Transurethral Resection of the Bladder
Eligibility Criteria
You may qualify if:
- The patients should be indicated for a cystoscopic examination for suspected or verified papillary bladder cancer and fulfill one or more of the following 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
You may not qualify if:
- Patients with known tumors in the prostatic urethra or distal urethra
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Photocurelead
Study Sites (25)
Stanford Cancer Center, Department of Urology
Stanford, California, 94305-5820, United States
V.A. Medical Center
Gainesville, Florida, 32608, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
South Florida Clinical Research Center, Inc.
Pembroke Pines, Florida, 33028, United States
The Emory Clinic, Dept of Urology
Atlanta, Georgia, 30322, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
St. Joseph Mercy Hospital- Ann Arbor
Ann Arbor, Michigan, 48106, United States
Urologic Clinical Research Unit, Gonda 7102, Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Mount Sinai Medical Center, Department of Urology
New York, New York, 10029-6574, United States
URMC
Rochester, New York, 14642, United States
Urological Institute at Beachwood Cleveland Clinic
Beachwood, Ohio, 44120, United States
Thomas Jefferson Medical College, Department of Neurology
Philadelphia, Pennsylvania, 19107, United States
Vanderbilt University Medical Center, Department of Urologic Surgery
Nashville, Tennessee, 37232-2765, United States
Baylor College of Medicine, Scott Department of Urology
Houston, Texas, 77030-2726, United States
AKH, Klinik für Urologie der Universität Wien
Vienna, 1090, Austria
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
CHUQ Hotel-Dieu de Quebec
Québec, G1R 2J6, Canada
University Clinic of Giessen, Department of Urology
Giessen, 35392, Germany
Klinikum der Universität München-Großhardern, Urologische Klinik und Poliklinik
München, 81377, Germany
Urologische Klinik München-Planegg
Planegg, 82152, Germany
Akadem. Lehrkrankenhaus der Uni Regensburg, Klinik für Urologie
Regensburg, 93053, Germany
Universitätsklinik Tuebingen, Universitätsklinik für Urologie
Tübingen, 72076, Germany
Department of Urology, Academic Medical Center, University of Amsterdam
Amsterdam, 1105 AZ, Netherlands
Department of Urology, UMC St. Radboud
Nijmegen, 6500 HB, Netherlands
Related Publications (1)
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.
PMID: 20850152DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Yngvil Kloster Thomas
- Organization
- Photocure
Study Officials
- PRINCIPAL INVESTIGATOR
H Barton Grossman
The University of Texas, MD Anderson Cancer Center, Department of Urology
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2005
First Posted
October 5, 2005
Study Start
January 1, 2005
Primary Completion
July 1, 2008
Study Completion
August 1, 2008
Last Updated
October 11, 2013
Results First Posted
October 11, 2013
Record last verified: 2013-08