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A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02560584
Recruitment Status : Completed
First Posted : September 25, 2015
Results First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
KARL STORZ Endoscopy-America, Inc.
Information provided by (Responsible Party):
Photocure

Brief Summary:
The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during surveillance cystoscopy, using the KARL STORZ D-Light C PDD Flexible Videoscope System. Another purpose is to investigate if Cysview and blue light is safe and effective when used repeatedly.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Hexaminolevulinate hydrochloride Device: KARL STORZ D-Light C PDD Flexible Videoscope System Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

This is a prospective, open, comparative, within-patient controlled Phase 3 multicenter study in patients with bladder cancer. There is a maximum of three study visits for an enrolled patient:

Visit 1: Screening visit Visit 2: Surveillance cystoscopy in white light (WL) followed by blue light (BL) Visit 3: Operating room (OR) cystoscopy in WL followed by BL for patients with suspicion of recurrence after surveillance cystoscopy.

Cystoscopy in WL followed by BL is performed in all patients after Cysview instillation. Only patients with suspicious lesions at Visit 2 continue to a second cystoscopy in WL followed by BL at Visit 3.

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective, Open, Comparative, Within Patient Controlled Multicenter Phase 3 Study of Blue Light Cystoscopy With Cysview and White Light Cystoscopy Using KARL STORZ D-Light C PDD Flexible Videoscope System in Detection of Bladder Cancer in Patients With Bladder Cancer
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : April 5, 2017
Actual Study Completion Date : April 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Cysview arm

In this single-arm trial, Cystoscopy in white light followed by blue light (BL) is performed in all applicable patients during 2 study visits; Visit 2 (Surveillance) and Visit 3 (Operating room procedure)

All patients receive instillation of 100 mg hexaminolevulinate hydrochloride as intravesical solution (50 mL) in the bladder prior to cystoscopy. Retention time: 1-3 hours.

Surveillance cystoscopy is performed with the investigational device KARL STORZ D-Light C PDD Flexible Videoscope System

Drug: Hexaminolevulinate hydrochloride
Instillation in bladder
Other Name: Cysview

Device: KARL STORZ D-Light C PDD Flexible Videoscope System
Cystoscopy procedure




Primary Outcome Measures :
  1. Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy [ Time Frame: At time of cystoscopy procedure ]
    In the subsection of patients with histologically confirmed malignancy, the proportion of patients detected only by the use of blue light cystoscopy with Cysview is measured.


Secondary Outcome Measures :
  1. Proportion of Patients With Adverse Events Considered Causally Related to Cysview and/or Blue Light in the Surveillance Examination Compared With the OR Examination [ Time Frame: At time of cystoscopy procedure ]
  2. Proportion of Patients With One or More Carcinoma in Situ (CIS) Lesions Detected With Blue Light Cystoscopy With Cysview and None With White Light Cystoscopy [ Time Frame: At time of cystoscopy procedure ]
    In the subsection of patients with histologically confirmed CIS, the proportion of patients detected only by blue light cystoscopy with Cysview is measured.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Patients with bladder cancer in follow-up for tumor recurrence (Note: Patients must be included only at the first surveillance cystoscopy after a histologically confirmed tumor. The histologically confirmed tumor could either be from a TURB or from a surveillance cystoscopy where a biopsy was taken and a tumor was confirmed by histology)
  2. History of one or more of the following:

    • Multiple tumors
    • Recurrent tumors
    • High grade tumor(s)

Exclusion Criteria:

  1. Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in significant amounts of blood in the urine, which may visually limit cystoscopy. Where the haematuria is light, the patient should not be excluded, if in the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will alleviate the haematuria limitations to cystoscopy)
  2. Patients who cannot undergo in-office or operating room cystoscopy (Note: Training patients are eligible even if they cannot undergo operating room cystoscopy)
  3. Patients who have received Bacillus Calmette-Guérin (BCG) immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure
  4. Porphyria
  5. Known allergy to hexaminolevulinate hydrochloride or a similar compound
  6. Pregnancy or breast-feeding (all women of child-bearing potential must document a negative urine pregnancy test before study inclusion and use adequate contraception during the study
  7. Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days
  8. Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
  9. Patients that the investigator believes are unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the clinical study, uncooperative attitude or unlikelihood of completing the study

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): NCT02560584


Locations
Show Show 17 study locations
Sponsors and Collaborators
Photocure
KARL STORZ Endoscopy-America, Inc.
Investigators
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Principal Investigator: Mark Schoenberg, MD Montefiore Medical Center
Principal Investigator: J. Stephen Jones, MD The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Photocure:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Photocure
ClinicalTrials.gov Identifier: NCT02560584    
Other Study ID Numbers: PC B308/13
First Posted: September 25, 2015    Key Record Dates
Results First Posted: July 2, 2018
Last Update Posted: July 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers
Keywords provided by Photocure:
Non-muscle invasive bladder cancer
NMIBC
Cysview
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