Robot-Assisted Ultrasound for Thermal Ablative Therapy in Treating Patients With Small Kidney Masses Undergoing Surgery
NCT ID: NCT02370342
Last Updated: 2017-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2017-12-18
2019-12-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (robot-assisted laparoscopic HIFU)
Patients undergo robot-assisted laparoscopic HIFU thermal ablative therapy during partial nephrectomy.
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
Sonatherm 600i Ultrasonic Lesion Generating System
Device used for high-intensity focused ultrasound ablation
Interventions
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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
Sonatherm 600i Ultrasonic Lesion Generating System
Device used for high-intensity focused ultrasound ablation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Osamu Ukimura
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Keck Hospital of USC
Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2014-02636
Identifier Type: REGISTRY
Identifier Source: secondary_id
4K-14-3
Identifier Type: OTHER
Identifier Source: secondary_id
4K-14-3
Identifier Type: -
Identifier Source: org_study_id