Freehand Ultrasound Elasticity Imaging in Liver Surgery

Liver Tumors Clinical Trial

— IOUS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00942383
• Other study ID #: J0765
• Secondary ID: NA_00011327
• Status: Terminated
• Start date: September 2007
• Est. completion date: June 13, 2012

Study information

• Verified date: August 2011
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: June 13, 2012
• Est. primary completion date: June 13, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Neoplasms
• Liver Tumors

Locations

Country	Name	City	State
United States	SKCCC	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of transverse ablation diameter between intraoperative ultrasound elasticity imaging (USEI) and postoperative cross-sectional imaging (CT or MRI).		2 years
Secondary	Comparison of ablation volume between ultrasound elasticity imaging (USEI) and CT/MRI.		2 years
Secondary	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.		2 years
Secondary	Feasibility of image acquisition using Siemens Anteras clinical free-hand system.		2 years
Secondary	Feasibility of image processing and image segmentation using this clinical free-hand system.		2 years