Recruiting

Blue Light Cystoscopy

Sponsor:

Photocure

Code:

NCT02660645

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hexaminolevulinate hydrochloride (HCL)

Karl Storz D-Light C Photodynamic Diagnostic (PDD) system

Study Details

Brief summary:

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

Conditions

Bladder Cancer

Study ID

NCT02660645

Start date

Apr, 2014

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

4400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Hexaminolevulinate hydrochloride (HCL)

Instillation in bladder

Karl Storz D-Light C Photodynamic Diagnostic (PDD) system

Cystoscopy procedure

Primary outcome measure

  • Rate of detection of bladder malignancies [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Chad McKee, PhD

(919) 780-0417chad.mckee@photocure.com

Locations

The University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Charles Peyton, MD

ccpeyton@uab.edu

Principal Investigator:

Charles Peyton, MD

Mayo Clinic

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Mark Tyson, MD, MPH

tyson.mark@mayo.edu

Principal Investigator:

Mark Tyson, MD, MPH

USC/Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Ileana Aldana

323-865-0702ileana.aldana@med.usc.edu

Principal Investigator:

Sia Daneshmand, MD

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Karim Chamie, MD

310-794-7700

Principal Investigator:

Karim Chamie, MD

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Contacts

Dorothy Trivedi

dtrivedi@stanford.edu

Principal Investigator:

Joseph Liao, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Sima Porten, MD, MPH

415-885-3695Sima.Porten@ucsf.edu

Principal Investigator:

Sima Porten, MD, MPH

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Armine Smith, MD

202-660-5561

Principal Investigator:

Armine Smith, MD

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30097

Contacts

Vikram Narayan, MD

(404) 778-4898

Principal Investigator:

Vikram Narayan, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Joshua Meeks, MD

Northshore University Health System

Recruiting

Evanston, Illinois, United States, 60201

Principal Investigator:

Kristian Novakovic, MD

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Lehman G Jennifer, RN, CCRP

jgeck@iu.edu

Principal Investigator:

Hristos Z Kaimakliotis, MD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Jane Ledesma

913-588-8721jledesma2@kumc.edu

Principal Investigator:

John Taylor, MD, MS

Johns Hopkins Medicine

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Morgan De Carli

Mdecarl2@jhmi.edu

Principal Investigator:

Max Kates, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Maressa Twedt

612-626-6661twedt050@umn.edu

Principal Investigator:

Hamed Ahmadi, MD

NYU Langone's Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

Contacts

Gary Steinberg, MD

646-825-6300

Principal Investigator:

Gary Steinberg, MD

Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Kamal Pohar, MD

kamal.pohar@osumc.edu

Principal Investigator:

Kamal Pohar, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Rachel Link, CCRP

rachel.link@osumc.edu

Principal Investigator:

Kamal S Pohar, MD

Lexington Medical Center

Recruiting

West Columbia, South Carolina, United States, 29169

Contacts

Nicol Brandon

704-414-2870Nicol.brandon@carolinaurologypartners.com

Principal Investigator:

T. Brian Willard, MD

UT Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Yair Lotan, MD

214-645-8787

Principal Investigator:

Yair Lotan, MD

Michael E. DeBakey VA Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ashley Jones, BS, CCRP

713-791-1414Ashley.Jones2@bcm.edu

Principal Investigator:

Jennifer Taylor, MD, MPH

University of Washington Medicine

Recruiting

Seattle, Washington, United States, 98195

Contacts

John Gore, MD

(206) 598-4294

Principal Investigator:

John Gore, MD

More Information

Sponsor

Photocure

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Photocure on 2025-12-18.