Blue Light Resection for Bladder Cancer

Recruiting at 2 trial locations

Overseen By Domani Rodriguez

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Johns Hopkins University

Disqualifiers: Upper tract tumor, Muscle-invasive bladder cancer, Pelvic radiation, UTI, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for examining bladder tumors during surgery to determine which reduces cancer recurrence more effectively. One method uses regular white light, while the other employs a special blue light that may enhance the visibility and removal of cancerous tissue. The blue light method involves Cysview, a diagnostic drug that highlights cancer cells. Patients with bladder tumors undergoing surgery and who have recently started bladder-specific treatments might be suitable candidates. The trial aims to identify which lighting method better prevents cancer recurrence and improves long-term health outcomes. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients an opportunity to contribute to potentially groundbreaking treatment advancements.

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 prior data suggests that blue-light cystoscopy is safe for bladder cancer patients?

Research has shown that Blue Light Cystoscopy (BLC) with Cysview is generally safe for people. Previous studies reported common side effects such as bladder spasms, painful urination, blood in the urine, and bladder pain. These side effects were typical and usually not severe.

BLC is widely used to detect bladder cancer and is recognized as safe and effective for this purpose. It helps doctors see cancer more clearly, potentially leading to better treatment. Overall, using Cysview with BLC has proven to be a safe option for people with bladder cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of blue light cystoscopy (BLC) with Cysview for bladder cancer because it offers a more precise method for detecting tumors compared to the standard white light cystoscopy (WLC). While WLC is the traditional approach, BLC with Cysview involves using a special dye that makes cancerous cells glow under blue light. This enhanced visibility helps doctors spot and remove more tumors, potentially reducing the risk of cancer recurrence. This technique offers a significant advantage by providing clearer, more accurate results, which can lead to better treatment outcomes for patients.

What evidence suggests that blue-light cystoscopy is effective for bladder cancer?

This trial will compare Blue Light Cystoscopy (BLC) with Cysview to White Light Cystoscopy (WLC) for bladder cancer. Research has shown that BLC with Cysview helps doctors find bladder tumors more effectively than WLC alone. Studies have found that BLC provides a clearer view of tumors, leading to better diagnosis and treatment of non-muscle invasive bladder cancer. This enhanced visibility can make tumor removal more precise, potentially reducing the chance of recurrence. Evidence also indicates that BLC is safe and effective for both detecting and monitoring bladder cancer. Overall, BLC with Cysview is an advanced technique that may improve long-term outcomes for patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Armine Smith, MD

Principal Investigator

Sibley Memorial Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Blue light Cystoscopy Experimental Treatment 2 Interventions

Patients with bladder tumors will undergo BLC TURBT

Group II: White light Cystoscopy Active Control 1 Intervention

Patients with bladder tumors will undergo WLC TURBT

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+

Published Research Related to This Trial

In a study of 178 patients with non-muscle invasive bladder cancer (NMIBC), NBI-assisted holmium laser resection (NBI-HoLRBt) significantly reduced the 1-year recurrence rate to 18.60% compared to 38.04% in the traditional white light imaging (WLI) group.

The NBI-HoLRBt method also showed a lower in situ recurrence rate of 2.33% versus 14.13% in the WLI group, indicating its effectiveness in minimizing cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Narrow band imaging-assisted holmium laser resection reduced the recurrence rate of non-muscle invasive bladder cancer: a prospective, randomized controlled study]. Ma, T., Wang, W., Jiang, Z., et al.[2018]

In a study of 446 high-risk nonmuscle-invasive bladder cancer patients, blue-light cystoscopy combined with transurethral resection (TURBT) significantly reduced short-term recurrence rates compared to standard cystoscopy and resection, with an overall recurrence rate of 11.1% versus 31.2%.

Specifically, the blue-light group showed lower recurrence rates across all high-risk categories, including 4.3% for carcinoma in situ (CIS) and 10% for pTaG3 tumors, highlighting the efficacy of blue-light technology in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HAL blue-light cystoscopy in high-risk nonmuscle-invasive bladder cancer--re-TURBT recurrence rates in a prospective, randomized study. Geavlete, B., Jecu, M., Multescu, R., et al.[2016]

In a study of 64 patients undergoing radical cystectomy for bladder cancer, blue light cystoscopy (BLC) demonstrated significantly higher accuracy in detecting residual tumors compared to white light cystoscopy (WLC), with sensitivity rates of 87.1% for BLC versus 32.3% for WLC.

BLC was particularly effective in identifying carcinoma in situ (CIS), achieving a sensitivity of 92.6% compared to just 29.6% for WLC, highlighting its potential as a superior diagnostic tool in bladder cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Accuracy of Hexaminolevulinate in a Cohort of Patients Undergoing Radical Cystectomy. Pagliarulo, V., Alba, S., Gallone, MF., et al.[2018]

Blue light flexible cystoscopy significantly improves the detection of recurrent bladder cancer, identifying malignancies that were missed by white light cystoscopy in 20.6% of cases, including 34.6% of carcinoma in situ cases.

The procedure is safe, with no serious adverse events reported during surveillance, and it also detected additional malignant lesions in 46% of patients with confirmed malignancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study. Daneshmand, S., Patel, S., Lotan, Y., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Blue-light (BL) TURBT significantly reduces the risk of disease recurrence and progression in patients with non-muscle-invasive bladder cancer (NMIBC) compared to white-light (WL) TURBT, with evidence from 16 randomized controlled trials involving 4325 participants.

There were no increases in severe surgical complications associated with BL TURBT, suggesting it is a safe alternative to WL TURBT for bladder cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blue vs white light for transurethral resection of non-muscle-invasive bladder cancer: an abridged Cochrane Review. Maisch, P., Koziarz, A., Vajgrt, J., et al.[2022]

In a study of 282 patients with non-muscle invasive bladder cancer (NMIBC) undergoing blue light cystoscopy (BLC) after bacillus Calmette-Guérin (BCG) treatment, BLC detected 13% of recurrences that would have been missed by traditional white light cystoscopy (WLC), highlighting its efficacy in improving recurrence detection.

The false-positive rate for BLC was relatively low at 5%, indicating that while BLC is effective in identifying missed recurrences, healthcare providers should still discuss the potential for false-positive results with patients.

NCBI (Pubmed)

pubmed.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. Chappidi, MR., Yang, H., Meng, MV., et al.[2022]

Blue light cystoscopy (BLC) using hexaminolevulinate (Cysview®) significantly improves the detection of nonmuscle invasive bladder cancer (NMIBC) and is associated with lower recurrence rates and better recurrence-free survival.

False-positive results can occur in BLC due to specific scenarios such as inflammation, recent treatments, or certain anatomical features, but these can be minimized by adjusting the cystoscopic view and timing of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Diagnosis of Urothelial Bladder Cancer with Blue Light Cystoscopy via Recognition of False-Positive Lesions. Bazargani, ST., Djaladat, H., Schuckman, AK., et al.[2020]

An active surveillance program for patients with recurrent small bladder cancer (less than 10 mm) showed minimal risk, allowing for monitoring without immediate tumor resection, with 31 patients participating over a mean period of 16.1 months.

Out of 43 surveillance periods, most were terminated due to tumor growth or new tumors, but all resected tumors remained at stage Ta, indicating that this approach can be safe and effective for managing low-grade bladder tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active surveillance of low grade bladder tumors. Gofrit, ON., Shapiro, A.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of blue light flexible cystoscopy with hexaminolevulinate & the diagnosis of bladder cancer. Clinton, TN., Lotan, Y.[2019]

Blue light-enhanced transurethral resection of bladder cancer (TURBT) may significantly reduce the risk of disease recurrence and progression in patients with non-muscle invasive bladder cancer (NMIBC), with a hazard ratio of 0.66 for recurrence and 0.65 for progression based on a review of 16 trials involving 4325 participants.

There appears to be little or no difference in the risk of serious surgical complications between blue light and white light TURBT, suggesting that blue light TURBT is a safe alternative for treating NMIBC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blue versus white light for transurethral resection of non-muscle invasive bladder cancer. Maisch, P., Koziarz, A., Vajgrt, J., et al.[2023]

Blue light cystoscopy (BLC) significantly improves cancer detection and reduces recurrence during transurethral resection of bladder tumors (TURBT), yet it was only used in 1.2% of procedures from 2011 to 2020, indicating a concerning underutilization of this effective technique.

The use of BLC increased after the publication of updated guidelines in 2016 but plateaued by late 2018, with higher usage associated with academic hospitals and those performing more TURBT and radical cystectomy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Underutilization of Blue Light Cystoscopy for Bladder Cancer in the United States. Lewicki, P., Arenas-Gallo, C., Qiu, Y., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9527925/

The use of blue-light cystoscopy in the detection and ... Overall, BLC is a safe, effective method of enhanced imaging used in the diagnosis and surveillance of bladder cancer. Future research ...

2. cysviewhcp.com cysviewhcp.com/evidence-and-patient-cases/

Clinical evidence supporting use of Blue Light Cystoscopy ... Blue Light Cystoscopy (BLC®) with Cysview® improves detection vs. White Light Cystoscopy (WLC) alone in surgery and surveillance.

3. cysview.com cysview.com/

Official site for Cysview information Blue Light Cystoscopy with Cysview improves detection of non-muscle invasive bladder cancer. Learn more on the official website.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02560584

A Study of Blue Light Flexible Cystoscopy With Cysview in ... The purpose of this study is to investigate if blue light cystoscopy with Cysview improves detection of tumors in patients with bladder cancer during ...

5. canjurol.com canjurol.com/html/free-articles/V20I2_04F_DrGarfield.pdf

The cost-effectiveness of blue light cystoscopy The cost-effectiveness of blue light cystoscopy in bladder cancer detection: United. States projections based on clinical data showing. 4.5 years of follow up ...

6. urotoday.com urotoday.com/video-lectures/bladder-cancer/video/1197-patient-reported-outcomes-in-the-use-of-blue-light-cystoscopy-in-the-surveillance-of-bladder-cancer-angela-b-smith.html

Patient Reported Outcomes in the Use of Blue Light ... Angela Smith reviews the patient reported outcomes (PROs) outlined in the article "Efficacy and Safety of Flexible BLC with Cysview® in the Surveillance of ...