NCT03238664

Robot-Assisted Laparoscopic High-Intensity Focused Ultrasound and Radical Cystectomy for Thermal Ablation of Muscle Invasive Cells in Patients With Bladder Tumors

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Infiltrating Bladder Urothelial Carcinoma
• Stage II Bladder Urothelial Carcinoma
• Transitional Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo biopsy of bladder tumor
DEVICE	High-Intensity Focused Ultrasound Ablation	Undergo laparoscopic HIFU
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Radical Cystectomy	Undergo RARC
DEVICE	Ultrasonography	Undergo CEUS

Timeline

• Start date: 2018-01-22
• Primary completion: 2019-01-22
• Completion: 2020-01-22
• First posted: 2017-08-03
• Last updated: 2018-01-02

Regulatory

• FDA-regulated device study