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Freehand Ultrasound Elasticity Imaging in Liver Surgery (IOUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00942383
Recruitment Status : Terminated (low accrual)
First Posted : July 20, 2009
Last Update Posted : March 28, 2019
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Application of Novel, High Resolution, and Freehand Ultrasound Elasticity Imaging in Liver Surgery
Actual Study Start Date : September 2007
Actual Primary Completion Date : June 13, 2012
Actual Study Completion Date : June 13, 2012

Resource links provided by the National Library of Medicine

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

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

Secondary Outcome Measures :
  1. Comparison of ablation volume between ultrasound elasticity imaging (USEI) and CT/MRI. [ Time Frame: 2 years ]
  2. 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 ]
  3. Feasibility of image acquisition using Siemens Anteras clinical free-hand system. [ Time Frame: 2 years ]
  4. Feasibility of image processing and image segmentation using this clinical free-hand system. [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00942383

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United States, Maryland
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Principal Investigator: Michael A Choti, M.D. Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT00942383    
Other Study ID Numbers: J0765
NA_00011327 ( Other Identifier: JHM IRB )
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: August 2011
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
liver tumor
liver tumors
liver cancer
hepatocellular carcinoma
metastatic colorectal cancer
metastatic cancer to the liver
metastatic cancer
metastatic neuroendocrine cancer
liver surgery
radiofrequency ablation
microwave ablation
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liver Extracts