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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 : March 29, 2023
Sponsor:
Collaborator:
Catalyst Pharmaceutical Research
Information provided by (Responsible Party):
Photocure

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.

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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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

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


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

Locations
Show Show 21 study locations
Sponsors and Collaborators
Photocure
Catalyst Pharmaceutical Research
Investigators
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Principal Investigator: Siamak Daneshmand, MD University of Southern California
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    
Other Study ID Numbers: BLCCR-001
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: March 29, 2023
Last Verified: March 2023
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
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