Clinical trial NCT02370342: Robot-Assisted Ultrasound for Thermal Ablative Therapy in Treating Patients With Small Kidney Masses Undergoing Surgery
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Renal Carcinoma
Renal Mass
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Planned ablation volume
timeFrame: Baseline (day of surgery)
measure: Necrosis volume
timeFrame: Baseline (day of surgery)
Secondary outcomes:
measure: Tumor response
timeFrame: Up to 4 years
measure: Disease free interval
timeFrame: From the date of treatment to the date of local or distant failure or until date of death, assessed up to 4 years
measure: Time to local failure
timeFrame: From the date of treatment to the time to local failure, assessed up to 4 years
measure: Time to distant failure
timeFrame: From the date of treatment to the time to documented metastatic disease, assessed up to 4 years
measure: 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
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Osamu Ukimura
role: PRINCIPAL_INVESTIGATOR
References: