Freehand Ultrasound Elasticity Imaging in Liver Surgery (IOUS)

March 26, 2019 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Application of Novel, High Resolution, and Freehand Ultrasound Elasticity Imaging in Liver Surgery

The purpose of this study is to investigate the potential for visualizing radiofrequency-induced (RFA) and microwave-induced (MWA) hepatic thermal ablation lesions using a novel, high resolution, and freehand ultrasound elasticity imaging method in human subjects.

Study Overview

Status

Terminated

Conditions

Liver Tumors

Detailed Description

Study Procedures This is a prospective cohort study. Data will be collected from patients who have signed an informed consent form and are undergoing open, laparoscopic, or percutaneous RFA or MWA as their treatment for liver tumors. Their images will be assembled and correlated according to their IOUS characteristics plus processed strain images. Below is the description of how each aim will be accomplished.

Aim-1: Ultrasound Elasticity Imaging Acquisition. USEI data (both raw US data and B-mode data) will be recorded during standard operative ultrasound imaging used to guide thermal ablative therapy in the operating room. Images will be acquired before, during, and after RFA or MWA therapy. Raw data acquisition will be conducted using a Siemens Antares US scanner (Siemens Medical Solutions USA, Inc. Ultrasound Division, Issaquah, WA) with an ultrasound research interface (URI) to access raw US data. A Siemens VF 10-5 linear array will be used to acquire data using manual handling. Typically, the ultrasound probe is tracked and spatially registered with the coordinate frame of the of the CT images, so the pixels of the B-mode images are known in the coordinate frame of the CT volume. Thus if one localizes the target anatomy in the B-mode images, then the position of the target is automatically known with respect to the CT volume for validation of the performance of the elastography. The tracking beams are standard B-mode pulses (6.67 MHz center frequency, F/1.5 focal configuration, apodized, pulse repetition frequency (PRF) of 10.6 KHz, with a pulse length of 0.3μs). This US device is one of the standard machines available for clinical US.

We will track the ultrasound probe with an Electro-Magnetic (EM) tracker. The tracker has small sensors that can be attached to the ultrasound probe under the sterile cover of the ultrasound probe, and therefore the sensor is not exposed. Also, the tracker has a 'transmitter' that is flat and is placed underneath the patient below a soft cushion. The sensor is attached to the ultrasound probe prior to the surgery and hencethe probe will remain sterile. The transmitter is flat and will be placed under a soft cushion so that it does not cause any pressure effects on patient.

In both cases (raw data and B-mode), the freehand acquisition should allow for palpation (manual compression within few millimeters). Risks and discomforts are negligible: Interventional ultrasound is FDA-approved, and we will use only the data resulting from standard of care use of clinically certified equipment. The maximum length of a data recording session will be 1-2 minutes during standard ultrasound acquisition. We will acquire cine sequences for five defined periods: 1) tumor imaging before probe placement; 2) immediately after probe placement; 3) near completion during ablation; 4) two minutes following ablation with probe in place; and 5) after removing the ablator probe.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Maryland
  - Baltimore, Maryland, United States, 21287
    - SKCCC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who are undergoing open, laparoscopic or percutaneous radiofrequency ablation (RFA) or microwave ablation (MWA) as treatment for liver tumors.

Description

Inclusion Criteria:

Any patient eligible for open, laparoscopic, or percutaneous hepatic RFA or MWA as their surgical treatment due to either primary tumors of the liver as well as liver metastases.
Participants must be able to have post-operative CT/MRI at Johns Hopkins as their standard care.

Exclusion Criteria:

Patients under 18 years old.
Pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
IOUS-USEI Receive intraoperative ultrasound (IOUS) using the Siemens Anteras to acquire ultrasound elasticity imaging (USEI) during standard of care surgical radiofrequency ablation and microwave ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of transverse ablation diameter between intraoperative ultrasound elasticity imaging (USEI) and postoperative cross-sectional imaging (CT or MRI). Time Frame: 2 years	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of ablation volume between ultrasound elasticity imaging (USEI) and CT/MRI. Time Frame: 2 years	2 years
Correlation between "in vivo" versus phantom tumor size to validate the development of guidance systems combined with appropriate visualization and planning software for ablative therapy. Time Frame: 2 years	2 years
Feasibility of image acquisition using Siemens Anteras clinical free-hand system. Time Frame: 2 years	2 years
Feasibility of image processing and image segmentation using this clinical free-hand system. Time Frame: 2 years	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

Principal Investigator: Michael A Choti, M.D., Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2007

Primary Completion (Actual)

June 13, 2012

Study Completion (Actual)

June 13, 2012

Study Registration Dates

First Submitted

July 17, 2009

First Submitted That Met QC Criteria