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| Name | Class |
|---|---|
| Photocure ASA | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blue light Cystoscopy | Experimental | Patients with bladder tumors will undergo BLC TURBT |
|
| White light Cystoscopy | Active Comparator | Patients with bladder tumors will undergo WLC TURBT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cysview | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival | Recurrence-free survival rate will measured from the date of randomization to the first recurrence or to death from any cause. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Domani Rodriguez | Contact | 2026605561 | drodri59@jh.edu | |
| Armine Smith, MD | Contact | 2026605561 | asmit165@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Armine Smith, MD | Sibley Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sibley Memorial Hospital | Recruiting | Washington D.C. | District of Columbia | 20016 | United States | |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C419924 | 5-aminolevulinic acid hexyl ester |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Karl Storz D-Light C Photodynamic Diagnostic (PDD) system | Device | Cystoscopy procedure |
|
|
| Johns Hopkins University School of Medicine |
| Recruiting |
| Baltimore |
| Maryland |
| 21287 |
| United States |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |