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Freehand Ultrasound Elasticity Imaging in Liver Surgery (IOUS)

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ClinicalTrials.gov Identifier: NCT00942383
Recruitment Status : Unknown
Verified August 2011 by Sidney Kimmel Comprehensive Cancer Center.
Recruitment status was:  Recruiting
First Posted : July 20, 2009
Last Update Posted : August 8, 2011
Information provided by:
Sidney Kimmel Comprehensive Cancer Center

July 17, 2009
July 20, 2009
August 8, 2011
September 2007
September 2011   (Final data collection date for primary outcome measure)
Comparison of transverse ablation diameter between intraoperative ultrasound elasticity imaging (USEI) and postoperative cross-sectional imaging (CT or MRI). [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00942383 on ClinicalTrials.gov Archive Site
  • Comparison of ablation volume between ultrasound elasticity imaging (USEI) and CT/MRI. [ Time Frame: 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 ]
  • Feasibility of image acquisition using Siemens Anteras clinical free-hand system. [ Time Frame: 2 years ]
  • Feasibility of image processing and image segmentation using this clinical free-hand system. [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
Freehand Ultrasound Elasticity Imaging in Liver Surgery
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 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.

Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Liver Tumors
Device: IOUS - Siemens Anteras
additional IOUS to acquire ultrasound elasticity imaging
Experimental: IOUS-USEI
Receive additional intraoperative ultrasound using the Siemens Anteras to acquire ultrasound elasticity imaging plus standard of care intraoperative ultrasound
Intervention: Device: IOUS - Siemens Anteras
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
September 2013
September 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Michael Choti, Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
Not Provided
Principal Investigator: Michael A Choti, M.D. Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP