Blue Light Cystoscopy With Cysview® Registry (BLCCR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02660645|
Recruitment Status : Recruiting
First Posted : January 21, 2016
Last Update Posted : September 24, 2020
|Condition or disease||Intervention/treatment|
|Bladder Cancer||Drug: Hexaminolevulinate hydrochloride (HCL) Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system|
Data will be captured on specific patient types undergoing Blue Light Cystoscopy with Cysview for known or suspected non-muscle invasive bladder cancer. Specific clinical questions will be asked.
- What is the incremental detection rate with Blue Light Cystoscopy with Cysview over conventional white light cystoscopy in each of the seven (7) patient populations? Does this translate into lower recurrence/progression rate?
- How do the six (6) tumor variables used in the European Association of Urology (EAU) risk tables (primary/secondary, recurrence rate, size, multifocality, grade, and history of carcinoma in situ (CIS))6 affect this incremental rate?
- How does an abnormal cytology or positive or negative fluorescent in situ hybridization (FISH) affect the likelihood that Blue Light Cystoscopy with Cysview will detect more cancers than white light?
- What are the performance characteristics of Blue Light Cystoscopy with Cysview within eight (8) weeks of Bacillus Calmette-Guérin (BCG) with respect to improved tumor detection and false positive rate compared to conventional white light cystoscopy?
- What is the incremental Blue Light Cystoscopy with Cysview detection rate over random bladder biopsies alone in patients being evaluated for routine three month restaging (group 4) or occult disease (group 5)?
- What are the performance characteristics of Blue Light Cystoscopy with Cysview after repeated Blue Light Cystoscopy with Cysview evaluations with respect to improved tumor detection, false positive rate and safety compared to conventional white light?
- Does an abnormal urinalysis help identify patients with inflammation more likely to have false positive Blue Light Cystoscopy with Cysview results?
- What is the practical learning curve for becoming "proficient" with Blue Light Cystoscopy with Cysview?
- What is the overall false positive rate with Blue Light Cystoscopy with Cysview?
- Can Blue Light Cystoscopy with Cysview make the resection more complete? If yes, is this due to improved margins and/or additional tumors seen under blue light?
The Blue Light Cystoscopy with Cysview Registry is a web-based program supported by Global Vision Technologies. Data will be captured longitudinally over five (5) years on patients from each enrolled site. Each center will enter their respective site's patient data electronically.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||4400 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Blue Light Cystoscopy With Cysview® Registry|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Blue Light Cystoscopy with Cysview®
Bladder cancer patients who have undergone Blue light cystoscopy with Hexaminolevulinate hydrochloride (Cysview®) 100mg in 50 milliliters (mL) reconstituted solution instilled intravesically into bladder prior to cystoscopy in operating room (OR). Retention time: 1-3 hours. The Karl Storz D-Light C Photodynamic Diagnostic (PDD) system is used for the cystoscopy procedure at the OR examination.
Drug: Hexaminolevulinate hydrochloride (HCL)
Instillation in bladder
Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
- Rate of detection of bladder malignancies [ Time Frame: 5 years ]Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone.
- False-positive detection rates [ Time Frame: 5 years ]Rates of false-positive lesion biopsies based on pathological findings
- Higher-Quality resection rates with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone [ Time Frame: 5 years ]Rate of additional margin detection with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone
- Proportion of patients with adverse events considered causally related to Cysview in repeat administration. [ Time Frame: 5 years ]Adverse events reporting
- Recurrence Rates [ Time Frame: 5 years ]Recurrence rates NMIBC in patients whose lesions were detected with Blue Light Cystoscopy with Cysview
- Cystectomy Rate [ Time Frame: 5 years ]Proportion of patients who have a cystectomy performed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660645
|Contact: Anthony Fernandez||(609) 759 firstname.lastname@example.org|
|United States, California|
|USC/Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Ileana Aldana 323-865-0702 email@example.com|
|Principal Investigator: Sia Daneshmand, MD|
|Sub-Investigator: Anne Schuckman, MD|
|Sub-Investigator: Mihir Desai, MD|
|Sub-Investigator: Hooman Djaladat, MD|
|Sub-Investigator: Gerhard Fuchs, MD|
|Sub-Investigator: Virinder Bhardwaj, MD|
|VA Palo Alto Health Care System||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Dorothy Trivedi firstname.lastname@example.org|
|Principal Investigator: Joseph Liao, MD|
|Sub-Investigator: James Crotty, MD|
|Sub-Investigator: John Leppert, MD|
|Sub-Investigator: John Lavelle, MD|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Sima Porten, MD, MPH 415-885-3695 Sima.Porten@ucsf.edu|
|Principal Investigator: Sima Porten, MD, MPH|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Katie Glavin 913-588-8721 email@example.com|
|Principal Investigator: John Taylor, MD, MS|
|Sub-Investigator: Jeffrey Holzbeierlein, MD, FACS|
|Sub-Investigator: Eugene Lee, MD, FACS|
|Sub-Investigator: Hadley Wyre, MD|
|Sub-Investigator: Moben Mirza, MD|
|United States, Maryland|
|Johns Hopkins Medicine||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Morgan De Carli Mdecarl2@jhmi.edu|
|Principal Investigator: Trinity Bivalacqua, MD, PhD|
|Sub-Investigator: Phillip Pierorazio, MD|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Therese Perrier 612-625-3319 firstname.lastname@example.org|
|Principal Investigator: Badrinath Konety, MD|
|Sub-Investigator: Weight Chris, MD|
|Sub-Investigator: Laureen Hemsley, MD|
|United States, New York|
|Stony Brook Urology||Suspended|
|Stony Brook, New York, United States, 11794|
|United States, Ohio|
|Cincinnati VA Medical Center||Withdrawn|
|Cincinnati, Ohio, United States, 45220|
|Ohio State University Wexner Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Kamal Pohar, MD email@example.com|
|Principal Investigator: Kamal Pohar, MD|
|Sub-Investigator: Megan Merrill, DO|
|Sub-Investigator: Ahmad Shabsigh, MD|
|Sub-Investigator: David Sharp, MD|
|United States, South Carolina|
|Carolina Urology Partners||Recruiting|
|West Columbia, South Carolina, United States, 29169|
|Contact: Nicol Brandon 704-414-2870 ext 2809 Nicol.firstname.lastname@example.org|
|Principal Investigator: T. Brian Willard, MD|
|Sub-Investigator: David Lamb, MD|
|Sub-Investigator: Scott Sweazy, MD|
|Sub-Investigator: Keith Birghtbill, MD|
|Sub-Investigator: Michael Stotzer, MD|
|United States, Texas|
|UT Southwestern||Not yet recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Yair Lotan, MD 214-645-8787|
|Principal Investigator: Yair Lotan, MD|
|Sub-Investigator: Aditya Bagrodia, MD|
|Sub-Investigator: Vitaly Margulis, MD|
|Sub-Investigator: Ganesh Raj, MD, PhD|
|Michael E. DeBakey VA Medical Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Ashley Jones, BS, CCRP 713-791-1414 ext 26694 Ashley.Jones2@bcm.edu|
|Principal Investigator: Jennifer Taylor, MD, MPH|
|Sub-Investigator: Jeffrey Jones, MD|
|Sub-Investigator: Sidney Worsham, MD|
|United States, West Virginia|
|Charleston Area Medical Center||Terminated|
|Charleston, West Virginia, United States, 25301|
|Principal Investigator:||Siamak Daneshmand, MD||University of Southern California|