Bladder CancerPhase 3NCT02560584

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

A Phase 3 study testing Hexaminolevulinate hydrochloride and KARL STORZ D-Light C PDD Flexible Videoscope System in people with Bladder Cancer, run by Photocure at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bladder Cancer
What is being tested?: Hexaminolevulinate hydrochloride and KARL STORZ D-Light C PDD Flexible Videoscope System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 304 participants
Where: 17 sitesUnited States
Study dates: 1 Oct 2015to 5 Apr 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Johns Hopkins University
Baltimore, Maryland, 21205
University of North Carolina, Department of Urology
Chapel Hill, North Carolina, 27599
University of Chicago Medical Center
Chicago, Illinois, 60637
Ohio State University The James Cancer Hospital
Columbus, Ohio, 43210
UT Southwestern Medical Center
Dallas, Texas, 75390
MD Anderson Cancer Center
Houston, Texas, 77030
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Wisconsin
Madison, Wisconsin, 53792
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU Langone Urology Associates
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
University of Oklahoma-Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Thomas Jefferson University
Philadelphia, Pennsylvania, 10197
Montefiore Medical Center
The Bronx, New York, 10461

Other trials in United States

About this study

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

Conditions: Bladder Cancer
Being tested: Hexaminolevulinate hydrochloride, KARL STORZ D-Light C PDD Flexible Videoscope System
Keywords: Non-muscle invasive bladder cancer, NMIBC, Cysview
Medical subject headings: Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hexaminolevulinate hydrochlorideDrug
Also called Cysview
Instillation in bladder
KARL STORZ D-Light C PDD Flexible Videoscope SystemDevice
Cystoscopy procedure

Study groups in NCT02560584
Study group	Role	What they receive
Cysview arm	Experimental	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 Receives: Drug: Hexaminolevulinate hydrochloride; Device: KARL STORZ D-Light C PDD Flexible Videoscope System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At time of cystoscopy procedure

Secondary outcomes (2)

Proportion of Patients With Adverse Events Considered Causally Related to Cysview and/or Blue Light in the Surveillance Examination Compared With the OR Examination
Measured: At time of cystoscopy procedure
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.
Measured: At time of cystoscopy procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20155 Apr 2017

First posted25 Sep 2015 (estimated)
Study start1 Oct 2015
Primary completion5 Apr 2017
Study completion5 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Bladder CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 304 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02560584
Sponsor's protocol ID: PC B308/13
Status last verified: May 2018
First submitted: 23 Sep 2015
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: IPD will not be shared with other researchers

Publications

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.
PubMed 35750559
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.
PubMed 29979488
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.
PubMed 29203268

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
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Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
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All Bladder Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02560584
Acronym / sponsor ID: PC B308/13
Conditions: Bladder Cancer
Keywords: Non-muscle invasive bladder cancer, NMIBC, Cysview
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 304 participants (actual)
Lead sponsor: PhotocureIndustry (pharma, biotech, devices)
Collaborators: KARL STORZ Endoscopy-America, Inc.
Study start: 1 Oct 2015 (actual)
Primary completion: 5 Apr 2017 (actual)
Study completion: 5 Apr 2017 (actual)
First posted: 25 Sep 2015 (estimated)
Results: Posted 2 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Cysview arm	Experimental	Drug: Hexaminolevulinate hydrochloride, Device: KARL STORZ D-Light C PDD Flexible Videoscope SystemIn 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hexaminolevulinate hydrochlorideAlso: CysviewInstillation in bladder	Drug	Cysview arm
KARL STORZ D-Light C PDD Flexible Videoscope SystemCystoscopy procedure	Device	Cysview arm

Primary outcome

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.

2 secondary outcomes

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
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

Results and safety

Results posted to the registry on 2 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cysview Arm	304	304

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Cysview Arm n = 63
Value	13

Cysview Arm: p <0.0001, Exact one-sided test for a single propor

Population analysed: Patients with histologically confirmed malignancy

2 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cysview Arm	1 of 304 (0.3%)	17 of 304 (5.6%)	0 of 304

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35750559Pohar 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.
Derived from this study: PubMed 29979488Smith 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.
Derived from this study: PubMed 29203268Daneshmand 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.
Individual participant dataSharing planned: No. IPD will not be shared with other researchers

Related trials for Bladder Cancer

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Schoenberg, MD principal investigator

Montefiore Medical Center

J. Stephen Jones, MD principal investigator

The Cleveland Clinic

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hexaminolevulinate hydrochloride and KARL STORZ D-Light C PDD Flexible Videoscope System in people with Bladder Cancer, run by Photocure at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02560584, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.