Blue Light Cystoscopy With Cysview® Registry (BLCCR)
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ClinicalTrials.gov Identifier: NCT02660645 |
Recruitment Status :
Recruiting
First Posted : January 21, 2016
Last Update Posted : March 29, 2023
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Condition or disease | Intervention/treatment |
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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 |
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 2028 |
Estimated Study Completion Date : | December 2028 |

Group/Cohort | Intervention/treatment |
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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.
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Drug: Hexaminolevulinate hydrochloride (HCL)
Instillation in bladder
Other Names:
Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system Cystoscopy procedure |
- 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

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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 |
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

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: Chad McKee, PhD | (919) 780-0417 | chad.mckee@photocure.com |

Principal Investigator: | Siamak Daneshmand, MD | University of Southern California |
Publications of Results:
Responsible Party: | Photocure |
ClinicalTrials.gov Identifier: | NCT02660645 |
Other Study ID Numbers: |
BLCCR-001 |
First Posted: | January 21, 2016 Key Record Dates |
Last Update Posted: | March 29, 2023 |
Last Verified: | March 2023 |
Cysview Hexaminolevulinate Hexvix NMIBC BLCC Blue Light Cystoscopy with Cysview |
Cystoscopy TURBT TUR Fluorescent cystoscopy Non-muscle invasive bladder cancer (NMIBC) Transurethral resection (TUR) |
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Urinary Bladder Diseases Urologic Diseases Male Urogenital Diseases Aminolevulinic Acid Photosensitizing Agents Dermatologic Agents |