Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses

NCT02248389 | Completed Phase 1 DMC

• 1 other identifier: IUCRO-0474
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Renal Cell

Keywords

carcinoma, renal cell; ablation; laparoscopic surgery; high intensity focused ultrasound

Outcome Measures

Primary Outcomes (1)

• Operative and postoperative complications

  Observing complications as defined by the Clavien system (1-5).

  4-months

Secondary Outcomes (3)

• Necrosis

  1-week

• Tumor targeting

  1-week

• Surgeon rated ease of use

  1-week

Study Arms (1)

Ablation arm

EXPERIMENTAL

Each person in study will receive ablation of their renal tumor followed by standard partial nephrectomy.

Device: Sonatherm 600i ablation system

Interventions

Sonatherm 600i ablation system DEVICE

HIFU ablation of tumor.

Ablation arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age.
• Must provide written informed consent
• Must have presence of an enhancing solid renal mass ≤ 3.0 cm on CT or MRI
• Must be scheduled for laparoscopic robot assisted partial nephrectomy of renal mass.
• Must have an expected survival status of at least 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
• 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.
• 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.
• All toxicities from prior therapy must be recovered to a grade 1 or better according to the Clavien-Dindo Classification system.
• If previous biopsy of mass has been done, pathology must be consistent with renal cell carcinoma (RCC).

You may not qualify if:

• \< 90% solid component of the tumor on screening cross-sectional imaging (CT/MRI)
• Prior ablative or surgical treatment of the lesion
• Masses located close to the hilar vessels or at locations that cannot be accessed with the HIFU probe
• The patient has only one kidney
• Multiple or bilateral renal masses
• Failure to meet the following laboratory levels on preoperative screening:
• Platelet count ≥ 100,000 mm3
• Hemoglobin ≥ 10 g/dl.
• Prothrombin Time (PT) ≤ 1.5 times upper limit of laboratory normal (ULN).
• Activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN.
• Serum creatinine \< 2.5 times ULN.
• Hepatic toxicity grade 2 (using CTCAE version 4 standard definitions)
• Inability to hold anticoagulation for surgery due to high risk of a cerebral vascular event, myocardial event, or like risk (ASA may be continued)
• Abdominal obesity that would, in the assessment of the PI, make the HIFU ablation difficult
• Participation in another investigational trial concurrently or within 30 days prior to enrollment

Sponsors & Collaborators

• Indiana University: lead
• SonaCare Medical: collaborator

Study Sites (1)

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology, Director of Minimally Invasive Surgery

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: September 25, 2014
• Study Start: September 4, 2014
• Primary Completion: June 8, 2015
• Study Completion: June 8, 2015
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

US (1)