Trial Outcomes & Findings for A Study of Blue Light Flexible Cystoscopy With Cysview in the Detection of Bladder Cancer in the Surveillance Setting (NCT NCT02560584)

NCT ID: NCT02560584

Last Updated: 2018-07-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 304 participants
• Primary outcome timeframe: At time of cystoscopy procedure
• Results posted on: 2018-07-02

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	304
Overall Study COMPLETED	304
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cysview Arm n=304 Participants 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
Age, Continuous	69.0 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants
Sex: Female, Male Male	242 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	296 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants
Race (NIH/OMB) White	272 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Number of Previous Recurrences	1.7 number of previous recurrences STANDARD_DEVIATION 2.0 • n=5 Participants
History of CIS	127 Participants n=5 Participants
History of High Grade (Grade 2 or 3) Ta or T1	222 Participants n=5 Participants
Patients Treated with intravesical chemotherapy	114 Participants n=5 Participants
Patients with Previous Treatment with BCG Immunotherapy	251 Participants n=5 Participants

PRIMARY outcome

Timeframe: At time of cystoscopy procedure

Population: Patients with histologically confirmed malignancy

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.

Outcome measures

Measure	Cysview Arm n=63 Participants 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	Surveillance + OR Examination Patients who received a Cysview instillation in both surveillance and OR examinations.
Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy	13 Participants	—

SECONDARY outcome

Timeframe: At time of cystoscopy procedure

Population: 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.

Outcome measures

Measure	Cysview Arm n=304 Participants 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	Surveillance + OR Examination n=103 Participants Patients who received a Cysview instillation in both surveillance and OR examinations.
Proportion of Patients With Adverse Events Considered Causally Related to Cysview and/or Blue Light in the Surveillance Examination Compared With the OR Examination	6 Participants	3 Participants

SECONDARY outcome

Timeframe: At time of cystoscopy procedure

Population: Number of patients with histologically confirmed CIS

In the subsection of patients with histologically confirmed CIS, the proportion of patients detected only by blue light cystoscopy with Cysview is measured.

Outcome measures

Measure	Cysview Arm n=26 Participants 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	Surveillance + OR Examination Patients who received a Cysview instillation in both surveillance and OR examinations.
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	9 Participants	—

Adverse Events

Cysview Arm

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure

Cysview Arm n=304 participants at risk 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

Respiratory, thoracic and mediastinal disorders Aspiration, Pneumonia aspiration

0.33% 1/304 • Number of events 2 • 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.

Other adverse events

Measure	Cysview Arm n=304 participants at risk 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
Renal and urinary disorders Bladder discomfort, Bladder pain, Bladder spasm, Dysuria, Urethral pain, Urinary bladder hemorrhage	3.9% 12/304 • Number of events 14 • 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.
Injury, poisoning and procedural complications Procedural pain	0.66% 2/304 • Number of events 2 • 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.
General disorders Pain, Pyrexia	0.66% 2/304 • Number of events 2 • 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.
Skin and subcutaneous tissue disorders Dermatitis contact, erythema, priuritus	0.66% 2/304 • Number of events 3 • 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.
Gastrointestinal disorders Nausea	0.33% 1/304 • Number of events 1 • 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.

Additional Information

Dr. J. Stephen Jones

Regional Hospitals & Family Health Centers

Phone: +1-216-442-5060

Email: joness7@cff.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60