Transitional Cell Carcinoma Clinical Trial
Official title:
Robot-Assisted Laparoscopic HIFU (High-Intensity Focused Ultrasound) of the Bladder Wall for Thermal Ablation of Muscle Invasive Cells of Bladder Tumors: Corroborating With Robot-Assisted Radical Cystectomy
This randomized pilot trial studies how well robot-assisted laparoscopic high-intensity focused ultrasound works compared to robot-assisted radical cystectomy for thermal ablation of muscle invasive cells in patients with bladder tumors. Laparoscopic high-intensity focused ultrasound uses high frequency sound waves to deliver a strong beam to a specific part of the tumor and may lower the number of tumor cells released into the blood stream compared to radical cystectomy.
PRIMARY OBJECTIVES:
I. To obtain preliminary estimates of the efficacy of laparoscopic high-intensity focused
ultrasound (HIFU) for the treatment of localized primary bladder cancer.
II. To estimate the change in the number of expelled circulating tumor cells (CTCs), when
comparing HIFU to robot-assisted radical cystectomy (RARC) alone.
SECONDARY OBJECTIVES:
I. To evaluate the safety and toxicity of using laparoscopic HIFU.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo pre-HIFU contrast-enhanced ultrasound (CEUS), standard of care biopsy
of the bladder tumor, laparoscopic HIFU, and post-HIFU CEUS. Patients then undergo standard
of care RARC.
ARM B: Patients undergo standard of care RARC.
After completion of study, patients are followed up at 2 weeks and 3 months.
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