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

December 18, 2017 updated by: University of Southern California

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Withdrawn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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline (day of surgery)
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
Time Frame: Baseline (day of surgery)
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
Time Frame: Up to 4 years
Up to 4 years
Disease free interval
Time Frame: From the date of treatment to the date of local or distant failure or until date of death, assessed up to 4 years
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
Time Frame: From the date of treatment to the time to local failure, assessed up to 4 years
From the date of treatment to the time to local failure, assessed up to 4 years
Time to distant failure
Time Frame: From the date of treatment to the time to documented metastatic disease, assessed up to 4 years
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
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Osamu Ukimura, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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