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

Renal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02370342
• Other study ID #: 4K-14-3
• Secondary ID: NCI-2014-026364K
• Status: Withdrawn
• Phase: N/A
• First received: February 17, 2015
• Last updated: December 18, 2017
• Start date: December 18, 2017
• Est. completion date: December 18, 2019

Study information

• Verified date: December 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 18, 2019
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Carcinoma
• Renal Mass

Intervention

Procedure:
• Robot-Assisted Laparoscopic Surgery
Undergo robot-assisted laparoscopic HIFU ablation
• High-Intensity Focused Ultrasound Ablation
Undergo robot-assisted laparoscopic HIFU ablation
• Therapeutic Laparoscopic Surgery
Undergo laparoscopic partial nephrectomy

Device:
• Sonatherm 600i Ultrasonic Lesion Generating System
Device used for high-intensity focused ultrasound ablation

Locations

Country	Name	City	State
United States	Keck Hospital of USC	Los Angeles	California
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Tumor response		Up to 4 years
Secondary	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
Secondary	Time to local failure		From the date of treatment to the time to local failure, assessed up to 4 years
Secondary	Time to distant failure		From the date of treatment to the time to documented metastatic disease, assessed up to 4 years
Secondary	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