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

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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Bladder Cancer
Interventions Drug: Hexaminolevulinate hydrochloride
Device: KARL STORZ D-Light C PDD Flexible Videoscope System
Enrollment 304
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cysview Arm
Hide Arm/Group 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

Period Title: Overall Study
Started 304
Completed 304
Not Completed 0
Arm/Group Title Cysview Arm
Hide Arm/Group 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

Overall Number of Baseline Participants 304
Hide Baseline Analysis Population Description
This is a single-arm trial. All participants received the same intervention. All enrolled participants received Cysview and an examination in the office and were referred to a second procedure in the operating room if medically indicated in the first examination. Baseline characteristics are reported for all enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 304 participants
69.0  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 304 participants
Female
62
  20.4%
Male
242
  79.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 304 participants
Hispanic or Latino
6
   2.0%
Not Hispanic or Latino
296
  97.4%
Unknown or Not Reported
2
   0.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 304 participants
American Indian or Alaska Native
0
   0.0%
Asian
10
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
20
   6.6%
White
272
  89.5%
More than one race
0
   0.0%
Unknown or Not Reported
2
   0.7%
Number of Previous Recurrences  
Mean (Standard Deviation)
Unit of measure:  Number of previous recurrences
Number Analyzed 304 participants
1.7  (2.0)
History of CIS  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 304 participants
127
  41.8%
History of High Grade (Grade 2 or 3) Ta or T1   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 304 participants
222
  73.0%
[1]
Measure Description: Under the American Joint Committee on Cancer (AJCC) staging system, also known as the Tumor-Node-Metastases (TNM), pathological stages of NMIBC includes the following: (1) papillary tumors confined to the epithelial mucosa (stage Ta), (2) tumors invading the subepithelial tissue (i.e., lamina propria; T1), and (3) carcinoma in situ. The 1973 World Health Organization (WHO) classification was the widely accepted format for grading bladder neoplasia. The 1973 version designated tumors as either papilloma, grade 1, 2, or 3, whereas the 2004 revision designated tumors as 'low' or 'high' grade.
Patients Treated with intravesical chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 304 participants
114
  37.5%
Patients with Previous Treatment with BCG Immunotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 304 participants
251
  82.6%
1.Primary Outcome
Title Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with histologically confirmed malignancy
Arm/Group Title Cysview Arm
Hide Arm/Group 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

Overall Number of Participants Analyzed 63
Measure Type: Count of Participants
Unit of Measure: Participants
13
  20.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cysview Arm
Comments

The proportion of patients with malignancy detected only with BLC with Cysview was to be analyzed using an exact one-sided test for a single proportion based on the cumulative binomial distribution with a significance level of 2.5%.

Null hypothesis: Malignancy is detected with BL only in 0.5% or less of the patients

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Exact one-sided test for a single propor
Comments [Not Specified]
2.Secondary Outcome
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
Hide Description [Not Specified]
Time Frame At time of cystoscopy procedure
Hide Outcome Measure Data
Hide Analysis Population Description
This is a within patient control trial, where the white light (WL) cystoscopy was the comparator. Enrolled participants received a WL and blue light (BL) surveillance examination after Cysview instillation. Operating room (OR) cystoscopy in WL and BL was performed for patients with suspicion of recurrence after surveillance cystoscopy.
Arm/Group Title Surveillance Examination Surveillance + OR Examination
Hide Arm/Group Description:
Patients who received Cysview instillation in the surveillance examination.
Patients who received a Cysview instillation in both surveillance and OR examinations.
Overall Number of Participants Analyzed 304 103
Measure Type: Count of Participants
Unit of Measure: Participants
6
   2.0%
3
   2.9%
3.Secondary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with histologically confirmed CIS
Arm/Group Title Cysview Arm
Hide Arm/Group 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

Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
9
  34.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cysview Arm
Comments

The proportion of patients with one or more CIS lesions detected with BL and none with WL was to be evaluated using an exact binomial test for single proportion with a significance level of 2.5% (one-sided).

Null hypothesis: One or more CIS lesions are detected with BLC with Cysview and none with WL in less than or equal to 0.1% of the patients.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Exact one-sided test for single proporti
Comments [Not Specified]
Time Frame The period of observation in the surveillance examination was defined as the period from instillation of Cysview until the patient left the hospital. The period of observation in the operating room examination was defined as the period from instillation of Cysview until hospital discharge or for a maximum of 24 hours after the instillation if the patient was still at the hospital.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cysview Arm
Hide Arm/Group 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

All-Cause Mortality
Cysview Arm
Affected / at Risk (%)
Total   0/304 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cysview Arm
Affected / at Risk (%) # Events
Total   1/304 (0.33%)    
Respiratory, thoracic and mediastinal disorders   
Aspiration, Pneumonia aspiration  1  1/304 (0.33%)  2
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cysview Arm
Affected / at Risk (%) # Events
Total   17/304 (5.59%)    
Gastrointestinal disorders   
Nausea  1  1/304 (0.33%)  1
General disorders   
Pain, Pyrexia  1  2/304 (0.66%)  2
Injury, poisoning and procedural complications   
Procedural pain  1  2/304 (0.66%)  2
Renal and urinary disorders   
Bladder discomfort, Bladder pain, Bladder spasm, Dysuria, Urethral pain, Urinary bladder hemorrhage  1  12/304 (3.95%)  14
Skin and subcutaneous tissue disorders   
Dermatitis contact, erythema, priuritus  1  2/304 (0.66%)  3
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. J. Stephen Jones
Organization: Regional Hospitals & Family Health Centers
Phone: +1-216-442-5060
Responsible Party: Photocure
ClinicalTrials.gov Identifier: NCT02560584     History of Changes
Other Study ID Numbers: PC B308/13
First Submitted: September 23, 2015
First Posted: September 25, 2015
Results First Submitted: March 21, 2018
Results First Posted: July 2, 2018
Last Update Posted: July 2, 2018