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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Renal Carcinoma, Renal Mass

Intervention / Treatment
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* Procedure: Robot-Assisted Laparoscopic Surgery
* Procedure: High-Intensity Focused Ultrasound Ablation
* Procedure: Therapeutic Laparoscopic Surgery
* Device: Sonatherm 600i Ultrasonic Lesion Generating System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (robot-assisted laparoscopic HIFU)<br>Patients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy. | Procedure: Robot-Assisted Laparoscopic Surgery<br>* Undergo robot-assisted laparoscopic HIFU ablation<br>Procedure: High-Intensity Focused Ultrasound Ablation<br>* Undergo robot-assisted laparoscopic HIFU ablation<br>* Other names: HIFU;Procedure: Therapeutic Laparoscopic Surgery<br>* Undergo laparoscopic partial nephrectomy<br>Device: Sonatherm 600i Ultrasonic Lesion Generating System<br>* Device used for high-intensity focused ultrasound ablation<br>* Other names: Sonatherm;|

What is the study measuring?
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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 | Measure Description | 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 |