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

Primary Purpose

Renal Carcinoma, Renal Mass

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robot-Assisted Laparoscopic Surgery
High-Intensity Focused Ultrasound Ablation
Therapeutic Laparoscopic Surgery
Sonatherm 600i Ultrasonic Lesion Generating System
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keck Hospital of USC
  • USC Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (robot-assisted laparoscopic HIFU)

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Tumor response
Disease free interval
Time to local failure
Time to distant failure
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

Full Information

First Posted
February 17, 2015
Last Updated
December 18, 2017
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02370342
Brief Title
Robot-Assisted Ultrasound for Thermal Ablative Therapy in Treating Patients With Small Kidney Masses Undergoing Surgery
Official Title
Robot-Assisted Laparoscopic HIFU (High-Intensity Focused Ultrasound) for Thermal Ablative Therapy of Small Renal Mass: Corroborating With Robot-Assisted Laparoscopic Partial Nephrectomy Specimens
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
December 18, 2017 (Anticipated)
Primary Completion Date
December 18, 2018 (Anticipated)
Study Completion Date
December 18, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Carcinoma, Renal Mass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (robot-assisted laparoscopic HIFU)
Arm Type
Experimental
Arm Description
Patients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy.
Intervention Type
Procedure
Intervention Name(s)
Robot-Assisted Laparoscopic Surgery
Intervention Description
Undergo robot-assisted laparoscopic HIFU ablation
Intervention Type
Procedure
Intervention Name(s)
High-Intensity Focused Ultrasound Ablation
Other Intervention Name(s)
HIFU
Intervention Description
Undergo robot-assisted laparoscopic HIFU ablation
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Laparoscopic Surgery
Intervention Description
Undergo laparoscopic partial nephrectomy
Intervention Type
Device
Intervention Name(s)
Sonatherm 600i Ultrasonic Lesion Generating System
Other Intervention Name(s)
Sonatherm
Intervention Description
Device used for high-intensity focused ultrasound ablation
Primary Outcome Measure Information:
Title
Planned ablation volume
Description
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.
Time Frame
Baseline (day of surgery)
Title
Necrosis volume
Description
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.
Time Frame
Baseline (day of surgery)
Secondary Outcome Measure Information:
Title
Tumor response
Time Frame
Up to 4 years
Title
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
Title
Time to local failure
Time Frame
From the date of treatment to the time to local failure, assessed up to 4 years
Title
Time to distant failure
Time Frame
From the date of treatment to the time to documented metastatic disease, assessed up to 4 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osamu Ukimura
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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

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