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

Withdrawn before enrolling · Not applicable

Conditions studied: Renal Carcinoma, Renal Mass

In brief

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.

Key facts

Study ID

NCT02370342

Run by

University of Southern California

People needed

0

Starts

2017-12-18

Expected to finish

2019-12-18

Last updated by the study team

2017-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• < 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

Where it is running

• Keck Hospital of USC — Los Angeles, California, United States
• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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