Freehand Ultrasound Elasticity Imaging in Liver Surgery (IOUS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Sidney Kimmel Comprehensive Cancer Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00942383
First received: July 17, 2009
Last updated: August 5, 2011
Last verified: August 2011
  Purpose

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 Intervention
Liver Tumors
Device: IOUS - Siemens Anteras

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Application of Novel, High Resolution, and Freehand Ultrasound Elasticity Imaging in Liver Surgery

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Comparison of transverse ablation diameter between intraoperative ultrasound elasticity imaging (USEI) and postoperative cross-sectional imaging (CT or MRI). [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of ablation volume between ultrasound elasticity imaging (USEI) and CT/MRI. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Feasibility of image acquisition using Siemens Anteras clinical free-hand system. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Feasibility of image processing and image segmentation using this clinical free-hand system. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2007
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IOUS-USEI
Receive additional intraoperative ultrasound using the Siemens Anteras to acquire ultrasound elasticity imaging plus standard of care intraoperative ultrasound
Device: IOUS - Siemens Anteras
additional IOUS to acquire ultrasound elasticity imaging

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942383

Contacts
Contact: Michael Choti, MD 410-955-7113 mchoti@jhmi.edu
Contact: Alice Delaney, BS MA MEd 443-287-4558 adelane7@jhmi.edu

Locations
United States, Maryland
SKCCC Recruiting
Baltimore, Maryland, United States, 21287
Contact: Michael Choti, MD    410-955-7113      
Principal Investigator: Michael Choti, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Michael A Choti, M.D. Sidney Kimmel Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Michael Choti, Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00942383     History of Changes
Other Study ID Numbers: J0765, NA_00011327
Study First Received: July 17, 2009
Last Updated: August 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
liver tumor
liver tumors
liver cancer
hepatocellular carcinoma
metastatic colorectal cancer
metastatic cancer to the liver
metastatic cancer
metastatic neuroendocrine cancer
liver
liver surgery
radiofrequency ablation
microwave ablation

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 24, 2014