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

Not Applicable

Withdrawn

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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment (robot-assisted laparoscopic HIFU)	Therapeutic Laparoscopic Surgery	Patients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy.
Treatment (robot-assisted laparoscopic HIFU)	Sonatherm 600i Ultrasonic Lesion Generating System	Patients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy.
Treatment (robot-assisted laparoscopic HIFU)	Robot-Assisted Laparoscopic Surgery	Patients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy.
Treatment (robot-assisted laparoscopic HIFU)	High-Intensity Focused Ultrasound Ablation	Patients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy.

Primary Outcome Measures

Name	Time	Method
Necrosis volume	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.
Planned ablation volume	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.

Secondary Outcome Measures

Name	Time	Method
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
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
Tumor response	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

Locations (2): Keck Hospital of USC
🇺🇸
Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
🇺🇸
Los Angeles, California, United States