Freehand Ultrasound Elasticity Imaging in Liver Surgery

NCT ID: NCT00942383

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2012-06-13

Brief 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.

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.

Conditions

Liver Tumors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A Choti, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

SKCCC

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00011327

Identifier Type: OTHER

Identifier Source: secondary_id

J0765

Identifier Type: -

Identifier Source: org_study_id