Blue Light Cystoscopy With Cysview® Registry (BLCCR)

• ClinicalTrials.gov Identifier: NCT02660645
• Recruitment Status: Recruiting
• First Posted: January 21, 2016
• Last Update Posted: September 24, 2020
• 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

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 4400 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 2021
• Estimated Study Completion Date: December 2021

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

Secondary Outcome Measures :

1. False-positive detection rates [ Time Frame: 5 years ]
   Rates of false-positive lesion biopsies based on pathological findings
2. 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
3. Proportion of patients with adverse events considered causally related to Cysview in repeat administration. [ Time Frame: 5 years ]
   Adverse events reporting
4. Recurrence Rates [ Time Frame: 5 years ]
   Recurrence rates NMIBC in patients whose lesions were detected with Blue Light Cystoscopy with Cysview
5. Cystectomy Rate [ Time Frame: 5 years ]
   Proportion of patients who have a cystectomy performed

Eligibility Criteria

• 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

Contact: Anthony Fernandez; (609) 759 6500; af@photocure.com

Locations

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; 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 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; Terminated

Charleston, West Virginia, United States, 25301

Sponsors and Collaborators

Photocure

KARL STORZ Endoscopy-America, Inc.

Investigators

• 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.

• Responsible Party: Photocure
• ClinicalTrials.gov Identifier: NCT02660645
• Other Study ID Numbers: BLCCR-001
• First Posted: January 21, 2016
• Last Update Posted: September 24, 2020
• Last Verified: September 2020

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:

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