Ultrasound-Guided Core Needle Biopsy to Stage Urothelial Carcinoma of the Bladder (US UCB)

PRIMARY OBJECTIVES:

I. To evaluate the feasibility and accuracy of using an Ultrasound-guided (US) core needle biopsy, a technology commonly used for gastrointestinal and bronchial cancer staging, as a potential staging tool for urothelial carcinoma of the bladder (UCB) in radical cystectomy specimens immediately after surgery, ensuring no risk to the patient.

II. To compare the staging results obtained from different clinical methods, including US-assessed tumor stage, US-core needle biopsy stage, the current gold-standard clinical staging method (pre-cystectomy TURBT), and image-based diagnostic methods (e.g., VI-RADS), as available for select patients.

III. To determine the concordance between each clinical staging method and the final pathologic tumor stage in radical cystectomy specimens, aiming to identify the most accurate approach for UCB staging.

IV. To compare the accuracy of US-core needle biopsy, and TURBT for determining variant histology.

V. To compare the concordance between clinical staging methods to the final pathologic tumor stage in radical cystectomy specimens containing urothelial carcinoma.

VI. To explore the ability for US to determine bladder tumor dimensions and growth patterns.

VII. To further enhance staging accuracy, we are incorporating intravenous ultrasound (IVUS) and optical coherence tomography (OCT) catheters into the protocol.

OUTLINE: This is an observational study.

Patients undergo standard of care radical cystectomy and residual tissues collected undergo US core needle biopsy. Additionally, patients have their medical records reviewed on study.