Robot-Assisted Ultrasound for Thermal Ablative Therapy in Treating Patients With Small Kidney Masses Undergoing Surgery

Robot-Assisted Laparoscopic HIFU (High-Intensity Focused Ultrasound) for Thermal Ablative Therapy of Small Renal Mass: Corroborating With Robot-Assisted Laparoscopic Partial Nephrectomy Specimens

This clinical trial studies a type of ultrasound called robot-assisted laparoscopic high-intensity focused ultrasound for performing thermal ablative therapy, or sound wave therapy, in treating patients with small kidney masses undergoing partial removal of the kidney. The robot-assisted ultrasound probe takes images of the kidney to help doctors locate the mass. The probe then uses high frequency sound waves to target and ablate (or destroy) the kidney mass, which may be a cancerous tumor or benign tissue. Surgery is then performed to remove the part of the kidney with the mass. Robot-assisted laparoscopic high-intensity focused ultrasound for thermal ablative therapy may be safer and help doctors see the tumor better when performing kidney surgery.

Study Overview

• Status: Withdrawn
• Conditions: Renal Carcinoma; Renal Mass
• Intervention / Treatment: Procedure: Robot-Assisted Laparoscopic Surgery; Procedure: High-Intensity Focused Ultrasound Ablation; Procedure: Therapeutic Laparoscopic Surgery; Device: Sonatherm 600i Ultrasonic Lesion Generating System

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of laparoscopic high-intensity focused ultrasound (HIFU) for the treatment of localized primary renal cancer to evaluate histological accuracy in successful ablation of the small renal mass, matched with intraoperative targeting.

SECONDARY OBJECTIVES:

I. To evaluate the safety and toxicity of laparoscopic HIFU for patients with primary renal cancer.

II. To evaluate the technical success of laparoscopic HIFU ablation.

OUTLINE:

Patients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy.

After completion of study treatment, patients are followed up at 2 days, 2 weeks, 1 month, 6 months, 12 months, and then annually for up to 3 years.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90033
      • Keck Hospital of USC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of an enhancing solid renal mass =< 3.0 cm on radiological examination
• Tumors with a depth of not greater than 3.0 cm from a laparoscopically accessible surface-meaning no part of the tumor should be deeper than 3.0 cm from the surface
• Patients with solitary kidneys, bilateral renal tumors, compromised renal function (baseline creatinine > 1.4)
• Subjects must have given written informed consent
• 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
• Subjects must be free of any clinically significant disease other than cancer that would interfere with the study evaluations
• 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
• Urea and serum creatinine < 2.5 times ULN
• Total bilirubin < 1.5 times ULN
• Aspartate aminotransferase (AST) =< 3 times ULN
• Alkaline phosphatase < 2 times ULN, unless arising from bone

Exclusion Criteria:

• < 90% solid component on screening cross-sectional imaging
• Subjects deemed unsuitable candidates and not medically optimized for partial nephrectomy
• Tumors greater than 3.0 cm at their widest point
• Subjects with tumors lying < 1 cm from sensitive structures such as the ureter, renal vessels or adjacent bowel
• Subjects on concurrent anticoagulant, or immunosuppressive medication
• 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
• Subjects having had prior ablation therapy on the same tumor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (robot-assisted laparoscopic HIFU); Patients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy.

Procedure: Robot-Assisted Laparoscopic Surgery; Undergo robot-assisted laparoscopic HIFU ablation; Procedure: High-Intensity Focused Ultrasound Ablation; Undergo robot-assisted laparoscopic HIFU ablation; Other Names: HIFU; Procedure: Therapeutic Laparoscopic Surgery; Undergo laparoscopic partial nephrectomy; Device: Sonatherm 600i Ultrasonic Lesion Generating System; Device used for high-intensity focused ultrasound ablation; Other Names: Sonatherm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Planned ablation volume	Ablation area of the kidney mass will be compared to the planned area under histopathologic review. Analyzed using a one-sided one sample T-test.	Baseline (day of surgery)
Necrosis volume	Ablation area of the kidney mass will be compared to the planned area under histopathologic review. Analyzed using a one-sided one sample T-test.	Baseline (day of surgery)

Secondary Outcome Measures

Outcome Measure	Time Frame
Tumor response	Up to 4 years
Disease free interval	From the date of treatment to the date of local or distant failure or until date of death, assessed up to 4 years
Time to local failure	From the date of treatment to the time to local failure, assessed up to 4 years
Time to distant failure	From the date of treatment to the time to documented metastatic disease, assessed up to 4 years
Overall success rate, measured as the combination of achieving local control of kidney cancer and demonstration of a favorable safety profile evidenced by enumeration of all adverse events by type, severity, and frequency	Up to 4 years

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Osamu Ukimura, University of Southern California

Study record dates

Study Major Dates

• Study Start (Anticipated): December 18, 2017
• Primary Completion (Anticipated): December 18, 2018
• Study Completion (Anticipated): December 18, 2019

Study Registration Dates

• First Submitted: February 17, 2015
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (Estimate): February 24, 2015

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: 4K-14-3 (Other Identifier: USC Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2014-02636 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes