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

Primary Purpose

Carcinoma, Renal Cell

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Sonatherm 600i ablation system

About this trial

This is an interventional other trial for Carcinoma, Renal Cell focused on measuring carcinoma, renal cell, ablation, laparoscopic surgery, high intensity focused ultrasound

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥ 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).

Exclusion Criteria

< 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:
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.
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
Subjects with a diagnosis of metastatic disease who are currently receiving treatment or who are not in remission
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
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Sites / Locations

IU Health University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ablation arm

Arm Description

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

Outcomes

Primary Outcome Measures

Operative and postoperative complications

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

Secondary Outcome Measures

Necrosis

A microscopic analysis will be performed to assess necrosis within the ablation zone.

Tumor targeting

The ablation border beyond the tumor will be measured on pathologic analysis with success being defined as 1-10mm.

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.

Full Information

NCT ID

NCT02248389

First Posted

September 19, 2014

Last Updated

March 21, 2019

Sponsor

Indiana University

Collaborators

SonaCare Medical

1. Study Identification

Unique Protocol Identification Number

NCT02248389

Brief Title

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

Acronym

HIFU-KIDNEY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

September 4, 2014 (Actual)

Primary Completion Date

June 8, 2015 (Actual)

Study Completion Date

June 8, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

SonaCare Medical

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Renal Cell

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ablation arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Sonatherm 600i ablation system

Intervention Description

HIFU ablation of tumor.

Primary Outcome Measure Information:

Title

Operative and postoperative complications

Description

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

Time Frame

4-months

Secondary Outcome Measure Information:

Title

Necrosis

Description

A microscopic analysis will be performed to assess necrosis within the ablation zone.

Time Frame

1-week

Title

Tumor targeting

Description

The ablation border beyond the tumor will be measured on pathologic analysis with success being defined as 1-10mm.

Time Frame

1-week

Title

Surgeon rated ease of use

Description

A questionnaire assessing the ease of use of the Sonatherm instrument will be given to the surgeon after each case.

Time Frame

1-week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥ 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). Exclusion Criteria < 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 Subjects with a diagnosis of metastatic disease who are currently receiving treatment or who are not in remission 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 -

Facility Information:

Facility Name

IU Health University Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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