Blue Light Cystoscopy With Cysview® Registry (BLCCR)

• Sponsor: Photocure
• Collaborator: KARL STORZ Endoscopy-America, Inc.
• Information provided by (Responsible Party): Photocure

Study Description

Brief Summary:

Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.

Condition or disease	Intervention/treatment
Bladder Cancer	Drug: Hexaminolevulinate hydrochloride (HCL); Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system

Detailed Description:

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.

1. 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?
2. 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?
3. 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?
4. 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?
5. 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)?
6. 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?
7. Does an abnormal urinalysis help identify patients with inflammation more likely to have false positive Blue Light Cystoscopy with Cysview results?
8. What is the practical learning curve for becoming "proficient" with Blue Light Cystoscopy with Cysview?
9. What is the overall false positive rate with Blue Light Cystoscopy with Cysview?
10. 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 Design

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	2000 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Target Follow-Up Duration:	5 Years
Official Title:	Blue Light Cystoscopy With Cysview® Registry
Study Start Date :	April 2014
Estimated Primary Completion Date :	December 2020
Estimated Study Completion Date :	December 2020

Groups and Cohorts

Group/Cohort

Intervention/treatment

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; Other Names: Cysview®; Hexvix®; Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system; Cystoscopy procedure

Outcome Measures

Primary Outcome Measures :

1. Rate of detection of bladder malignancies with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone. [ Time Frame: 5 years ]

Secondary Outcome Measures :

1. False-positive detection rates [ Time Frame: 5 years ]
2. Complete resection rates with Blue Light Cystoscopy with Cysview versus white light cystoscopy alone [ Time Frame: 5 years ]
3. Proportion of patients with adverse events considered causally related to Cysview in repeat administration. [ Time Frame: 5 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients indicated for transurethral resection of the bladder.

Criteria

Inclusion Criteria:

• Adult >18 years old
• Suspected or known non-muscle invasive bladder cancer on the basis of a prior cystoscopy

Exclusion Criteria:

• Porphyria
• Gross hematuria
• Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives

Contacts and Locations

Contacts

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Contact: Hong Tran	(609) 759 6500	ht@photocure.com

Locations

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United States, California
USC/Norris Comprehensive Cancer Center	Recruiting
Los Angeles, California, United States, 90033
Contact: Ileana Aldana 323-865-0702 ileana.aldana@med.usc.edu
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 dtrivedi@stanford.edu
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 kglavin@kumc.edu
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 perri084@umn.edu
Principal Investigator: Badrinath Konety, MD
Sub-Investigator: Weight Chris, MD
Sub-Investigator: Laureen Hemsley, MD
United States, New York
Stony Brook Urology	Recruiting
Stony Brook, New York, United States, 11794
Contact: Kim Lyktey Kim.Lyktey@stonybrookmedicine.edu
Principal Investigator: John Fitzgerald, MD
Sub-Investigator: Massimiliano Spaliviero, MD
Sub-Investigator: Wayne Waltzer, MD
United States, Ohio
Cincinnati VA Medical Center	Not yet recruiting
Cincinnati, Ohio, United States, 45220
Contact: Krishnanath Gaitonde, MD
Principal Investigator: Krishnanath Gaitonde, MD
Ohio State University Wexner Medical Center	Recruiting
Columbus, Ohio, United States, 43210
Contact: Kamal Pohar, MD kamal.pohar@osumc.edu
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.brandon@carolinaurologypartners.com
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	Recruiting
Charleston, West Virginia, United States, 25301
Contact: James Tierney, DO 304-388-9944
Principal Investigator: James Tierney, DO
Sub-Investigator: Samuel Deem, DO

Sponsors and Collaborators

Photocure

KARL STORZ Endoscopy-America, Inc.

Investigators

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Principal Investigator:	Siamak Daneshmand, MD	University of Southern California

More Information

Additional Information:

Publications of Results:

Bazargani ST, Shah SH, Djaladat H, et al. Blue Light Cystoscopy For Diagnosis of Urothelial Bladder Cancer: Results: From A Prospective Registry. Poster presented at: The Annual meeting of Society of Urologic Oncology; December 2015; Washington, D.C.

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Responsible Party:	Photocure
ClinicalTrials.gov Identifier:	NCT02660645 History of Changes
Other Study ID Numbers:	BLCCR-001
First Posted:	January 21, 2016
Last Update Posted:	April 17, 2018
Last Verified:	April 2018

Keywords provided by Photocure:

Cysview; Hexaminolevulinate; Hexvix; NMIBC; BLCC; Blue Light Cystoscopy with Cysview	Cystoscopy; TURBT; TUR; Fluorescent cystoscopy; Non-muscle invasive bladder cancer (NMIBC); Transurethral resection (TUR)

Additional relevant MeSH terms:

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Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms	Urinary Bladder Diseases; Urologic Diseases; Aminolevulinic Acid; Photosensitizing Agents; Dermatologic Agents