200 Participants Needed

Blue Light Resection for Bladder Cancer

Recruiting at 1 trial location
AS
RC
Overseen ByRiziki Covington
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cysview in the Blue Light Resection for Bladder Cancer trial?

Research shows that using blue-light cystoscopy, which involves Cysview, improves the detection of bladder cancer and reduces the chance of the cancer coming back compared to traditional methods. This technique helps doctors see cancerous areas more clearly, leading to better treatment outcomes.12345

Is blue light cystoscopy with Cysview safe for humans?

Blue light cystoscopy with Cysview has been used in several studies and is generally considered safe for detecting bladder cancer, although it can sometimes show false positives (incorrect results indicating cancer). These false positives can be managed with experience and specific techniques, and the procedure has been approved by the FDA for use in certain settings.16789

How is the treatment Cysview unique for bladder cancer?

Cysview, used in blue light cystoscopy, helps doctors see bladder cancer more clearly during surgery by making cancer cells glow, which can lead to more complete removal and potentially lower recurrence rates compared to traditional white light methods.210111213

What is the purpose of this trial?

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.

Research Team

AS

Armine Smith, MD

Principal Investigator

Sibley Memorial Hospital

Eligibility Criteria

This trial is for adults over 18 with high-risk non-muscle invasive bladder cancer, who are undergoing TURBT and can start intravesical therapy within four weeks of the procedure. They must also have their upper urinary tract evaluated regularly during the study.

Inclusion Criteria

My upper body will be regularly checked during the study.
I am over 18 and will have a TURBT for my bladder tumor.
I started bladder treatment within 4 weeks after my bladder tumor surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either white-light cystoscopy (WLC) or blue-light cystoscopy (BLC) transurethral resection of bladder tumor (TURBT)

1 day
1 visit (in-person)

Follow-up

Participants are monitored for recurrence-free survival and minimal residual disease burden using cystoscopy, cytology, and urine next-generation sequencing

24 months
Every 3 months (in-person)

Treatment Details

Interventions

  • Cysview
Trial Overview The trial compares two types of cystoscopy used in tumor resection: traditional white-light (WLC) and blue-light (BLC) using Cysview with Karl Storz D-Light C system. It aims to see if BLC leads to better outcomes like lower recurrence rates by improving tumor visualization.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Blue light CystoscopyExperimental Treatment2 Interventions
Patients with bladder tumors will undergo BLC TURBT
Group II: White light CystoscopyActive Control1 Intervention
Patients with bladder tumors will undergo WLC TURBT

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Photocure ASA

Collaborator

Trials
1
Recruited
200+

Findings from Research

Blue-light cystoscopy significantly improves the detection of nonmuscle invasive bladder cancer, including difficult-to-detect carcinoma in situ, compared to traditional white-light cystoscopy, as shown in several randomized clinical trials.
This technique not only reduces the risk of cancer recurrence at 12 months but also shows potential for decreasing disease progression, although more research is needed to confirm these benefits and assess cost-effectiveness.
The use of blue-light cystoscopy in the detection and surveillance of nonmuscle invasive bladder cancer.Cahill, EM., Chua, K., Doppalapudi, SK., et al.[2022]
In a study of 249 patients with newly presenting non-muscle-invasive bladder cancer (NMIBC), photodynamic diagnosis using hexylaminolevulinate (HAL-PDD) was found to be effective in identifying occult carcinoma in situ, revealing secondary CIS in 26% of patients compared to 14% in the standard white-light group.
However, despite the improved diagnostic accuracy with HAL-PDD, there was no significant difference in recurrence rates of bladder cancer at 3 or 12 months when compared to standard white-light-assisted surgery, indicating that better diagnosis did not translate into lower recurrence.
Prospective randomized trial of hexylaminolevulinate photodynamic-assisted transurethral resection of bladder tumour (TURBT) plus single-shot intravesical mitomycin C vs conventional white-light TURBT plus mitomycin C in newly presenting non-muscle-invasive bladder cancer.O'Brien, T., Ray, E., Chatterton, K., et al.[2022]
A Phase III multicenter study involving 304 patients showed that blue light flexible cystoscopy (BLFC) significantly improved the detection of bladder cancer during surveillance, identifying 20.6% of malignancies that were missed by standard methods.
While BLFC enhances cancer detection, further research is needed to confirm if this leads to better clinical outcomes and to establish guidelines for its use in patient surveillance and cost-effectiveness.
The use of blue light flexible cystoscopy with hexaminolevulinate & the diagnosis of bladder cancer.Clinton, TN., Lotan, Y.[2019]

References

The use of blue-light cystoscopy in the detection and surveillance of nonmuscle invasive bladder cancer. [2022]
Prospective randomized trial of hexylaminolevulinate photodynamic-assisted transurethral resection of bladder tumour (TURBT) plus single-shot intravesical mitomycin C vs conventional white-light TURBT plus mitomycin C in newly presenting non-muscle-invasive bladder cancer. [2022]
The use of blue light flexible cystoscopy with hexaminolevulinate & the diagnosis of bladder cancer. [2019]
Underutilization of Blue Light Cystoscopy for Bladder Cancer in the United States. [2022]
[Narrow band imaging-assisted holmium laser resection reduced the recurrence rate of non-muscle invasive bladder cancer: a prospective, randomized controlled study]. [2018]
Diagnostic Accuracy of Hexaminolevulinate in a Cohort of Patients Undergoing Radical Cystectomy. [2018]
Optimizing Diagnosis of Urothelial Bladder Cancer with Blue Light Cystoscopy via Recognition of False-Positive Lesions. [2020]
Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study. [2022]
Active surveillance of low grade bladder tumors. [2016]
Blue vs white light for transurethral resection of non-muscle-invasive bladder cancer: an abridged Cochrane Review. [2022]
Blue versus white light for transurethral resection of non-muscle invasive bladder cancer. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
HAL blue-light cystoscopy in high-risk nonmuscle-invasive bladder cancer--re-TURBT recurrence rates in a prospective, randomized study. [2016]
13.United Statespubmed.ncbi.nlm.nih.gov
Utility of Blue Light Cystoscopy for Post-bacillus Calmette-Guérin Bladder Cancer Recurrence Detection: Implications for Clinical Trial Recruitment and Study Comparisons. [2022]
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