Bladder CancerPhase 3NCT06525571
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
A Phase 3 study testing Cysview and Karl Storz D-Light C Photodynamic Diagnostic (PDD) system in people with Bladder Cancer, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in TURBT for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. 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?
- Cysview and Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Dec 2024to 4 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Patients undergoing TURBT for radiographic or cystoscopic positive tumor
- 18+ years old
- Upper tract evaluated using standard of care throughout duration of the study
- Induction intravesical therapy initiated within four weeks of TURBT
Who cannot join
- Variant histology consisting of less than 50% urothelial carcinoma
- History, or current diagnosis, of upper tract tumor or muscle-invasive bladder cancer
- Prior history of pelvic radiation
- Active urinary tract infection (UTI)
- Patients who are noncompliant with the study protocol
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Rana Harb, 410-502-5500, rharb1@jhmi.edu
Faizah Karim, fkarim4@jh.edu
- Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in TURBT for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. Enhanced visualization with BLC may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. Patients will be randomized to either WLC TURBT or BLC TURBT, and outcomes will be measured using standard-of-care testing with cystoscopy and cytology, along with minimal residual disease (MRD) burden evaluation using urine next-generation sequencing.
Read the detailed description
Objectives are as follows:
Primary i) Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study, and among patients with a high-grade tumor at time of resection ii) Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study, and among all evaluable study participants.
Secondary i) Among all evaluable study participants: Recurrence-free survival (RFS) at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm.
ii) Among patients undergoing intravesical induction: Recurrence-free survival (RFS) at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm.
- Conditions
- Bladder Cancer
- Being tested
- Cysview, Karl Storz D-Light C Photodynamic Diagnostic (PDD) system
- Keywords
- Blue light cystoscopy, Cysview
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CysviewDrug
Also called Hexyl aminolevulinate (HAL)
Blue light cystoscopy uses hexyl aminolevulinate (HAL, branded in the United States as Cysview), a prodrug which accumulates in the bladder tumors and improves the tumor's visualization.
Karl Storz D-Light C Photodynamic Diagnostic (PDD) systemDevice
Also called Cystoscopy equipment to detect Cysview uptake in the bladder tumors
Cystoscopy procedure
| Study group | Role | What they receive |
|---|---|---|
| Blue light Cystoscopy | Experimental | Patients with bladder tumors will undergo BLC TURBT Receives: Drug: Cysview; Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system |
| White light Cystoscopy | Active comparator | Patients with bladder tumors will undergo WLC TURBT Receives: Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual disease burden
The residual tumor burden will be assessed by the standard of care testing, such as cystoscopy and cytology at 3 month intervals.
Measured: Up to 24 months
Minimal residual disease burden
Minimal residual disease (MRD) in urine will be measured utilizing the Convergent's UroAmp test at 3 month intervals.
Measured: Up to 24 months
Secondary outcomes (1)
Recurrence-free survival
Recurrence-free survival rate will measured from the date of randomization to the first recurrence or to death from any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start20 Dec 2024
- Primary completion4 Jan 2027 (estimated)
- Study completion4 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Photocure ASA
- Responsible party
- Sponsor
- Investigators
- Armine Smith, MD, Principal investigator, Sibley Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525571
- Sponsor's protocol ID
- IRB00442199
- Status last verified
- Nov 2026
- First submitted
- 24 Jul 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
- ClinicalTrials.gov ID
- NCT06525571
- Acronym / sponsor ID
- IRB00442199
- Conditions
- Bladder Cancer
- Keywords
- Blue light cystoscopy, Cysview
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Photocure ASA
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 4 Jan 2028 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in TURBT for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. Enhanced visualization with BLC may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. Patients will be randomized to either WLC TURBT or BLC TURBT, and outcomes will be measured using standard-of-care testing with cystoscopy and cytology, along with minimal residual disease (MRD) burden evaluation using urine next-generation sequencing.
Detailed description
Objectives are as follows:
Primary i) Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study, and among patients with a high-grade tumor at time of resection ii) Comparison of the reduction in MRD burden score between pre-resection and post-resection urine samples across BLC and WLC resection arms of the study, and among all evaluable study participants.
Secondary i) Among all evaluable study participants: Recurrence-free survival (RFS) at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm.
ii) Among patients undergoing intravesical induction: Recurrence-free survival (RFS) at 12 and 24 months using post-TURBT and three month surveillance urine sample time points in BLC and WLC arm.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blue light Cystoscopy | Experimental | Drug: Cysview, Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) systemPatients with bladder tumors will undergo BLC TURBT |
| White light Cystoscopy | Active comparator | Device: Karl Storz D-Light C Photodynamic Diagnostic (PDD) systemPatients with bladder tumors will undergo WLC TURBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing TURBT for radiographic or cystoscopic positive tumor
- 18+ years old
- Upper tract evaluated using standard of care throughout duration of the study
- Induction intravesical therapy initiated within four weeks of TURBT
Key exclusion criteria (5 listed)
- Variant histology consisting of less than 50% urothelial carcinoma
- History, or current diagnosis, of upper tract tumor or muscle-invasive bladder cancer
- Prior history of pelvic radiation
- Active urinary tract infection (UTI)
- Patients who are noncompliant with the study protocol
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 |
|---|---|---|
| CysviewAlso: Hexyl aminolevulinate (HAL)Blue light cystoscopy uses hexyl aminolevulinate (HAL, branded in the United States as Cysview), a prodrug which accumulates in the bladder tumors and improves the tumor's visualization. | Drug | Blue light Cystoscopy |
| Karl Storz D-Light C Photodynamic Diagnostic (PDD) systemAlso: Cystoscopy equipment to detect Cysview uptake in the bladder tumorsCystoscopy procedure | Device | Blue light Cystoscopy, White light Cystoscopy |
Primary outcome
Residual disease burden
Time frame: Up to 24 months
The residual tumor burden will be assessed by the standard of care testing, such as cystoscopy and cytology at 3 month intervals.
Minimal residual disease burden
Time frame: Up to 24 months
Minimal residual disease (MRD) in urine will be measured utilizing the Convergent's UroAmp test at 3 month intervals.
1 secondary outcome
Recurrence-free survival
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Bladder Cancer
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
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
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
Bladder Carcinoma, Breast Carcinoma
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.
Armine Smith, MD principal investigator
Sibley Memorial Hospital
2 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 Cysview and Karl Storz D-Light C Photodynamic Diagnostic (PDD) system in people with Bladder Cancer, run by Johns Hopkins University at 2 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domani Rodriguez (2026605561, drodri59@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual disease burden (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.