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

NCT02370342 | Withdrawn DMC FDA Device

• 3 other identifiers: 4K-14-3NCI-2014-02636P30CA014089
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Carcinoma; Renal Mass

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

Treatment (robot-assisted laparoscopic HIFU)

EXPERIMENTAL

Patients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy.

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

Interventions

Robot-Assisted Laparoscopic Surgery PROCEDURE

Undergo robot-assisted laparoscopic HIFU ablation

Treatment (robot-assisted laparoscopic HIFU)

High-Intensity Focused Ultrasound Ablation PROCEDURE

Undergo robot-assisted laparoscopic HIFU ablation

Also known as: HIFU

Treatment (robot-assisted laparoscopic HIFU)

Therapeutic Laparoscopic Surgery PROCEDURE

Undergo laparoscopic partial nephrectomy

Treatment (robot-assisted laparoscopic HIFU)

Sonatherm 600i Ultrasonic Lesion Generating System DEVICE

Device used for high-intensity focused ultrasound ablation

Also known as: Sonatherm

Treatment (robot-assisted laparoscopic HIFU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

High-Intensity Focused Ultrasound Ablation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Osamu Ukimura

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: February 24, 2015
• Study Start: December 18, 2017
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2019
• Last Updated: December 20, 2017

Record last verified: 2017-12

Locations

US (2)