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Spots Global Cancer Trial Database for Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB

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Trial Identification

Brief Title: Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB

Official Title: An Open, Non-interventional, Retrospective, Comparative, Multicenter Follow-up Study in Patients Included in the Previously Completed Clinical Study PCB305/04, to Assess Longer-term Recurrence Rates in Patients After Hexvix® (Cysview®)Fluorescence Cystoscopy/Transurethral Resection of the Bladder (TURB) or White Light Cystoscopy/TURB

Study ID: NCT01166230

Conditions

Bladder Cancer

Interventions

Study Description

Brief Summary: The study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB.

Detailed Description: A previously completed pivotal clinical study PC B305/04 demonstrated reduced recurrence rates for patients with papillary bladder cancer who underwent Hexvix (Cysview) and white light cystoscopy and transurethral resection (TURB) of the bladder compared to patients who underwent white light cystoscopy and TURB alone. The present study is intended to investigate whether the improved initial detection and resection of bladder cancer lesions in patients with non-muscle invasive bladder cancer with Hexvix (Cysview) fluorescence cystoscopy/TURB will also lead to a longer-term reduction in recurrences compared to standard white light cystoscopy/TURB. No safety data was collected.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

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

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

The University of Texas MD Anderson cancer center, Houston, Texas, United States

AKH, Klinik für Urologie der Universität Wien, Wien, , Austria

Kingston General Hospital, Kingston, Ontario, Canada

CHUQ Hotel-Dieu de Quebec, Quebec, , 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, Tuebingen, , Germany

Department of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, , Netherlands

Department of Urology, UMC St. Radboud, Nijmegen, , Netherlands

Contact Details

Name: Herbert Barton Grossman, MD

Affiliation: The University of Texas MD Anderson Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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