Blue Light Resection for Bladder Cancer
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?
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
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either white-light cystoscopy (WLC) or blue-light cystoscopy (BLC) transurethral resection of bladder tumor (TURBT)
Follow-up
Participants are monitored for recurrence-free survival and minimal residual disease burden using cystoscopy, cytology, and urine next-generation sequencing
Treatment Details
Interventions
- Cysview
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Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Photocure ASA
Collaborator