Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses (HIFU-KIDNEY)

The Sonatherm device provides both advanced imaging (ultrasound guidance) and high intensity focused ultrasound to target and ablate tumors. It also does not require piercing the tumor with a needle as does cryotherapy (Cryo) and radiofrequency (RF) ablation. Cryo and RF also have high retreatment rates due the finding of untreated tumor on follow-up imaging. Thus, there is reason to hypothesize that Sonatherm with it's real-time ultrasound imaging feedback could replace RF and Cryo for the treatment of small renal masses where the invasiveness of full resection partial nephrectomy is contraindicated due to patient comorbidities.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Renal Cell
• Intervention / Treatment: Device: Sonatherm 600i ablation system

Detailed Description

This study uses a treat and resect model where ablation is followed by a partial nephrectomy. This will allow for the ablation to be evaluated for necrosis and targeting accuracy. It will also ensure cancer safety prior validation of the HIFU device. The applied heat of HIFU ablation could improve hemostasis and blood loss.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ≥ 18 years of age.
2. Must provide written informed consent
3. Must have presence of an enhancing solid renal mass ≤ 3.0 cm on CT or MRI
4. Must be scheduled for laparoscopic robot assisted partial nephrectomy of renal mass.
5. Must have an expected survival status of at least 3 months.
6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
7. Previous chemotherapy, and/or biological therapy for cancer are permitted. The subject should have recovered from the effects of these or of any prior surgery.
8. Women of child bearing potential must have negative pregnancy test (urine or serum) prior to study enrollment. Females must agree to adequate birth control if conception is possible during the study.
9. All toxicities from prior therapy must be recovered to a grade 1 or better according to the Clavien-Dindo Classification system.
10. If previous biopsy of mass has been done, pathology must be consistent with renal cell carcinoma (RCC).

Exclusion Criteria

1. < 90% solid component of the tumor on screening cross-sectional imaging (CT/MRI)
2. Prior ablative or surgical treatment of the lesion
3. Masses located close to the hilar vessels or at locations that cannot be accessed with the HIFU probe
4. The patient has only one kidney
5. Multiple or bilateral renal masses

6. Failure to meet the following laboratory levels on preoperative screening:

   1. Platelet count ≥ 100,000 mm3
   2. Hemoglobin ≥ 10 g/dl.
   3. Prothrombin Time (PT) ≤ 1.5 times upper limit of laboratory normal (ULN).
   4. Activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN.
   5. Serum creatinine < 2.5 times ULN.
7. Hepatic toxicity grade 2 (using CTCAE version 4 standard definitions)
8. Inability to hold anticoagulation for surgery due to high risk of a cerebral vascular event, myocardial event, or like risk (ASA may be continued)
9. Abdominal obesity that would, in the assessment of the PI, make the HIFU ablation difficult
10. Participation in another investigational trial concurrently or within 30 days prior to enrollment
11. Subjects with a diagnosis of metastatic disease who are currently receiving treatment or who are not in remission

12. Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study

    -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ablation arm; Each person in study will receive ablation of their renal tumor followed by standard partial nephrectomy.	Device: Sonatherm 600i ablation system; HIFU ablation of tumor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative and postoperative complications	Observing complications as defined by the Clavien system (1-5).	4-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Necrosis	A microscopic analysis will be performed to assess necrosis within the ablation zone.	1-week
Tumor targeting	The ablation border beyond the tumor will be measured on pathologic analysis with success being defined as 1-10mm.	1-week
Surgeon rated ease of use	A questionnaire assessing the ease of use of the Sonatherm instrument will be given to the surgeon after each case.	1-week

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: SonaCare Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2014
• Primary Completion (Actual): June 8, 2015
• Study Completion (Actual): June 8, 2015

Study Registration Dates

• First Submitted: September 19, 2014
• First Submitted That Met QC Criteria: September 22, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: laparoscopic surgery; ablation; high intensity focused ultrasound; carcinoma, renal cell
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: IUCRO-0474