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

NCT ID: NCT03238664

Last Updated: 2018-01-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2020-01-22

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A (laparoscopic HIFU, RARC)

Patients undergo pre-HIFU CEUS, standard of care biopsy of the bladder tumor, laparoscopic HIFU, and post-HIFU CEUS. Patients then undergo standard of care RARC.

Group Type: EXPERIMENTAL

Biopsy

Intervention Type: PROCEDURE

Undergo biopsy of bladder tumor

High-Intensity Focused Ultrasound Ablation

Intervention Type: DEVICE

Undergo laparoscopic HIFU

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Radical Cystectomy

Intervention Type: PROCEDURE

Undergo RARC

Ultrasonography

Intervention Type: DEVICE

Undergo CEUS

Arm B (RARC)

Patients undergo standard of care RARC.

Group Type: ACTIVE_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Radical Cystectomy

Intervention Type: PROCEDURE

Undergo RARC

Interventions

Biopsy

Undergo biopsy of bladder tumor

Intervention Type: PROCEDURE

High-Intensity Focused Ultrasound Ablation

Undergo laparoscopic HIFU

Intervention Type: DEVICE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Radical Cystectomy

Undergo RARC

Intervention Type: PROCEDURE

Ultrasonography

Undergo CEUS

Intervention Type: DEVICE

Other Intervention Names

Bx; HIFU; high-intensity focused ultrasound therapy; Complete Cystectomy; 2-Dimensional Grayscale Ultrasound Imaging; 2-Dimensional Ultrasound Imaging; 2D-US; Ultrasound; Ultrasound Imaging; Ultrasound Test; Ultrasound, Medical; US

Eligibility Criteria

Exclusion Criteria

• Presence of a muscle invasive bladder tumor(s) (T2), specific for transitional cell carcinoma on pre-operative histology (i.e. biopsy or transurethral resection of bladder tumor [TURBT]).
• Presence of a single bladder tumor lesion
• Patients are scheduled to undergo RARC at our institution
• Subjects must have given written informed consent to agree to participate
• Previous chemotherapy, and/or biological therapy for cancer are permitted provided that the acoustic properties of the tumor were not affected, but the subject should have recovered from the effects of these or of any prior surgery; chemotherapy can be within 70 days of operation
• Subjects must be free of any clinically significant disease other than cancer that would interfere with the study evaluations
• Pre-operative computed tomography (CT)/magnetic resonance imaging (MRI) abdomen and pelvis within 90 days
• Absolute neutrophil count (ANC) >= 1500 mm^-3
• Platelet count >= 100,000 mm^-3
• Hemoglobin >= 10 g/dl
• Prothrombin time (PT) =< 1.5 times upper limit of laboratory normal (ULN)
• Activated partial thromboplastin time =< 1.5 times ULN
• Total bilirubin < 1.5 times ULN
• Aspartate aminotransferase (AST) =< 3 times ULN
• Alkaline phosphatase < 2 times ULN, unless arising from bone

• Subjects deemed unsuitable candidates and not medically optimized for RARC
• Subjects with tumors lying < 1 cm from sensitive structures such as the ureter, prostate or adjacent bowel
• Patients with presence of multiple bladder lesions
• Subjects on concurrent anticoagulant, or immunosuppressive medication
• Patients with pre-operative histologic confirmation of a bladder lesion other than transitional cell carcinoma
• Subjects on anti-cancer medication whether biologic or pharmaceutical
• Women who are pregnant or nursing (pregnancy test to be performed within 24 hours prior to HIFU treatment)
• Subjects assessed by consultant anesthetist as unsuitable for general anesthetic
• Absolute contraindications: venous injury at the level of the femoral veins or proximally; known or suspected thrombosis of the femoral or iliac veins on the proposed side of venous cannulation, ambulatory patient
• Relative contraindications: presence of bleeding disorders; distortion of anatomy due to local injury or deformity; previous long-term venous catheterization; history of vasculitis; previous injection of sclerosis agents; previous radiation therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Inderbir Gill, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Other Identifiers

NCI-2017-00626

Identifier Type: REGISTRY

Identifier Source: secondary_id

4B-15-6

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4B-15-6

Identifier Type: -

Identifier Source: org_study_id