Study to Improve Detection and Early Recurrence Rate in Bladder Cancer Patients Using Hexvix Fluorescence Cystoscopy

Completed · Phase 3

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT00233402

Run by

Photocure

People needed

789

Starts

2005-01-01

Expected to finish

2008-08-01

Last updated by the study team

2013-10-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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