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

NCT03238664 | Withdrawn DMC FDA Device

• 3 other identifiers: 4B-15-6NCI-2017-00626P30CA014089
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Complete ablation of the targeted lesion in the bladder wall assessed by histopathologic examination and Live/Dead Viability/Cytotoxicity Assay Kit of the resected specimen (Arm A)

  A Clopper-Pearson (exact) 90% confidence interval will be constructed for the probability of a successful HIFU procedure.

  At the day of surgery

• CTC enumeration assessed using quantitative real-time polymerase chain reaction

  The mean number of CTCs in each patient, as well as the difference between the two arms (possibly after log or square root transformation) will be estimated. Importantly the numbers of CTCs captured in the femoral lines will be compared to the numbers captured in the peripheral lines. Means and 90% confidence intervals will be calculated. Changes in CTC enumeration in a group that undergoes HIFU (Arm A) to a group that does not undergo HIFU (Arm B) will be observed.

  Up to 7 days post-surgery

Secondary Outcomes (1)

• Incidence of adverse events evaluated according to National Cancer Institute Criteria for Adverse Events version 4.0 (Arm A)

  Up to 3 months

Study Arms (2)

Arm A (laparoscopic HIFU, RARC)

EXPERIMENTAL

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.

Procedure: Biopsy; Device: High-Intensity Focused Ultrasound Ablation; Other: Laboratory Biomarker Analysis; Procedure: Radical Cystectomy; Device: Ultrasonography

Arm B (RARC)

ACTIVE COMPARATOR

Patients undergo standard of care RARC.

Other: Laboratory Biomarker Analysis; Procedure: Radical Cystectomy

Interventions

Biopsy PROCEDURE

Undergo biopsy of bladder tumor

Also known as: Bx

Arm A (laparoscopic HIFU, RARC)

High-Intensity Focused Ultrasound Ablation DEVICE

Undergo laparoscopic HIFU

Also known as: HIFU, high-intensity focused ultrasound therapy

Arm A (laparoscopic HIFU, RARC)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (laparoscopic HIFU, RARC); Arm B (RARC)

Radical Cystectomy PROCEDURE

Undergo RARC

Also known as: Complete Cystectomy

Arm A (laparoscopic HIFU, RARC); Arm B (RARC)

Ultrasonography DEVICE

Undergo CEUS

Also known as: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasound, Ultrasound Imaging, Ultrasound Test, Ultrasound, Medical, US

Arm A (laparoscopic HIFU, RARC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Biopsy; High-Intensity Focused Ultrasound Ablation; Extracorporeal Shockwave Therapy; Cystectomy; Ultrasonography

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Physical Therapy Modalities; Rehabilitation; Urologic Surgical Procedures; Urogenital Surgical Procedures; Diagnostic Imaging

Study Officials

• Inderbir Gill, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 3, 2017
• Study Start: January 22, 2018
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2020
• Last Updated: January 2, 2018

Record last verified: 2017-12