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

University of Southern California

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Renal Carcinoma Renal Mass

Interventions

Robot-Assisted Laparoscopic SurgeryPROCEDURE

Undergo robot-assisted laparoscopic HIFU ablation

High-Intensity Focused Ultrasound AblationPROCEDURE

Undergo robot-assisted laparoscopic HIFU ablation

Therapeutic Laparoscopic SurgeryPROCEDURE

Undergo laparoscopic partial nephrectomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Keck Hospital of USC

Los Angeles, California, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline (day of surgery)

Secondary Outcomes

Tumor response

Time frame: 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

Time to local failure

Time frame: 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

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

Data from ClinicalTrials.gov

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