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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hexaminolevulinate hydrochloride
KARL STORZ D-Light C PDD Flexible Videoscope System
Sponsored by
Photocure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring Non-muscle invasive bladder cancer, NMIBC, Cysview

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  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

Sites / Locations

  • USC Norris Comprehensive Cancer Center
  • University of Chicago Medical Center
  • University of Iowa
  • Johns Hopkins University
  • University of Minnesota
  • Montefiore Medical Center
  • NYU Langone Urology Associates
  • Columbia University Medical Center
  • University of North Carolina, Department of Urology
  • Ohio State University The James Cancer Hospital
  • University of Oklahoma-Stephenson Cancer Center
  • Thomas Jefferson University
  • Vanderbilt University Medical Center
  • UT Southwestern Medical Center
  • MD Anderson Cancer Center
  • Michael E. DeBakey VA Medical Center
  • University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cysview arm

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy
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

Proportion of Patients With Adverse Events Considered Causally Related to Cysview and/or Blue Light in the Surveillance Examination Compared With the OR Examination
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
In the subsection of patients with histologically confirmed CIS, the proportion of patients detected only by blue light cystoscopy with Cysview is measured.

Full Information

First Posted
September 23, 2015
Last Updated
May 31, 2018
Sponsor
Photocure
Collaborators
KARL STORZ Endoscopy-America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02560584
Brief Title
A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
April 5, 2017 (Actual)
Study Completion Date
April 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Photocure
Collaborators
KARL STORZ Endoscopy-America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Non-muscle invasive bladder cancer, NMIBC, Cysview

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cysview arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Hexaminolevulinate hydrochloride
Other Intervention Name(s)
Cysview
Intervention Description
Instillation in bladder
Intervention Type
Device
Intervention Name(s)
KARL STORZ D-Light C PDD Flexible Videoscope System
Intervention Description
Cystoscopy procedure
Primary Outcome Measure Information:
Title
Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy
Description
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.
Time Frame
At time of cystoscopy procedure
Secondary Outcome Measure Information:
Title
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
Title
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
Description
In the subsection of patients with histologically confirmed CIS, the proportion of patients detected only by blue light cystoscopy with Cysview is measured.
Time Frame
At time of cystoscopy procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) History of one or more of the following: Multiple tumors Recurrent tumors High grade tumor(s) Exclusion Criteria: 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) Patients who cannot undergo in-office or operating room cystoscopy (Note: Training patients are eligible even if they cannot undergo operating room cystoscopy) Patients who have received Bacillus Calmette-Guérin (BCG) immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure Porphyria Known allergy to hexaminolevulinate hydrochloride or a similar compound 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 Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Schoenberg, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Stephen Jones, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
NYU Langone Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina, Department of Urology
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Ohio State University The James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma-Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
10197
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers
Citations:
PubMed Identifier
35750559
Citation
Pohar KS, Patel S, Lotan Y, Trabulsi E, Woods M, Downs T, Huang WC, Jones J, Taylor J, O'Donnell M, Bivalacqua TJ, DeCastro J, Steinberg G, Kamat AM, Resnick MJ, Konety B, Schoenberg M, Jones JS, Daneshmand S; Flexible Blue Light Study Group Collaborators. Safety of repeat blue light cystoscopy with hexaminolevulinate (HAL) in the management of bladder cancer: Results from a phase III, comparative, multi-center study. Urol Oncol. 2022 Aug;40(8):382.e1-382.e6. doi: 10.1016/j.urolonc.2022.04.012. Epub 2022 Jun 22.
Results Reference
derived
PubMed Identifier
29979488
Citation
Smith AB, Daneshmand S, Patel S, Pohar K, Trabulsi E, Woods M, Downs T, Huang W, Taylor J, Jones J, O'Donnell M, Bivalacqua T, DeCastro J, Steinberg G, Kamat A, Resnick M, Konety B, Schoenberg M, Jones JS, Lotan Y; Flexible Blue Light Study Group Collaborators. Patient-reported outcomes of blue-light flexible cystoscopy with hexaminolevulinate in the surveillance of bladder cancer: results from a prospective multicentre study. BJU Int. 2019 Jan;123(1):35-41. doi: 10.1111/bju.14481. Epub 2018 Aug 11.
Results Reference
derived
PubMed Identifier
29203268
Citation
Daneshmand S, Patel S, Lotan Y, Pohar K, Trabulsi E, Woods M, Downs T, Huang W, Jones J, O'Donnell M, Bivalacqua T, DeCastro J, Steinberg G, Kamat A, Resnick M, Konety B, Schoenberg M, Jones JS; Flexible Blue Light Study Group Collaborators. Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study. J Urol. 2018 May;199(5):1158-1165. doi: 10.1016/j.juro.2017.11.096. Epub 2017 Dec 2. Erratum In: J Urol. 2019 May;201(5):1017.
Results Reference
derived

Learn more about this trial

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

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