<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02967198</url>
  </required_header>
  <id_info>
    <org_study_id>1508-099-695</org_study_id>
    <nct_id>NCT02967198</nct_id>
  </id_info>
  <brief_title>Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using CT or MR/US Fusing Imaging</brief_title>
  <official_title>Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using the Automatic Fusion Images of the Registrated 3D CT or MR-US Scans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether fusion technique of preradiofrequency&#xD;
      ablation (RFA) or percutaneous liver biopsy cross-sectional imaging (CT or MR) and real-time&#xD;
      ultrasonography would improve feasibility of RFA or liver biopsy in patients with liver tumor&#xD;
      in comparison with ultrasonography guidance alone. And assessment of a new point shear-wave&#xD;
      elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver&#xD;
      stiffness (LS) with another pSWE technique (ARFI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RFA is one of commonly used local therapies for primary or secondary liver tumors. And&#xD;
      percutaneous liver biopsy is very important technique to confirm the diagnosis of focal&#xD;
      hepatic lesion whether benign or malignancy.&#xD;
&#xD;
      For successful and safe procedure, safe access route and lesion visibility are essential ,&#xD;
      and the conditions are usually evaluated on pre-procedure planning ultrasonography (USG).&#xD;
      However, these procedure is sometimes aborted due to limited sonic window of various cause&#xD;
      and challenging identification of small isoechoic tumors or hepatocellular carcinomas among&#xD;
      dysplastic nodules . Therefore, precise targeting and assuring safe route would be of&#xD;
      clinical importance. In this preliminary study, investigators attempted to determine US and&#xD;
      CT/MR fusion technique would be able to improve RFA or liver biopsy feasibility in patients&#xD;
      with liver tumors in comparison with conventional US alone technique.&#xD;
&#xD;
      In addition, to assess intra- and inter-observer reproducibility of a new point shear-wave&#xD;
      elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver&#xD;
      stiffness (LS) with another pSWE technique (ARFI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>RFA or biopsy feasibility rates on planning USG with/without fusion CT/MR and US</measure>
    <time_frame>10 minutes after finishing planning USG</time_frame>
    <description>comparison of rates of RFA feasibility on conventional planning USG and on fusion planning USG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of a new point shear-wave elastography method (pSWE, S-shear wave)</measure>
    <time_frame>10 minutes after finishing planning USG</time_frame>
    <description>To assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of tumor visibility on planning USG with/without fusion technique</measure>
    <time_frame>10 minutes after finishing planning USG</time_frame>
    <description>comparison of tumor visibility (or detection) rates on planning USG on conventional planning USG and fusion planning USG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with safety access route on planning USG with/without fusion technique</measure>
    <time_frame>10 minutes after finishing planning USG</time_frame>
    <description>comparison of number of patients with presence/absence of safety access route, and the on two planning USGs</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">185</enrollment>
  <condition>Liver Mass</condition>
  <condition>Liver Fibroses</condition>
  <arm_group>
    <arm_group_label>CT/US fusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients undergo routine conventional feasibility planning ultrasound, and clinical decision of percutaneous liver biopsy or RFA feasibility is made based on conventional planning ultrasound. Then additional planning ultrasound using CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CT/US fusion</intervention_name>
    <description>Fusion of pre-procedure cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.</description>
    <arm_group_label>CT/US fusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ultrasound shear wave elastography</intervention_name>
    <description>ultrasound shear wave elastography is performed in S-shear wave scanner according to guidelines of ultrasound elastography.</description>
    <arm_group_label>CT/US fusion</arm_group_label>
    <other_name>S-shear wave</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all conditions should be satisfied for inclusion.&#xD;
&#xD;
               -  referred to Radiology in our institution for liver tumor RFA or percutaneous&#xD;
                  liver biopsy&#xD;
&#xD;
               -  available pre-procedure liver CT or liver MR imaging within 6 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any contraindication of liver RFA or percutaneous liver biopsy • any patients who&#xD;
             received treatment between pre-RFA imaging and planned RFA.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 16, 2016</last_update_submitted>
  <last_update_submitted_qc>November 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fusion</keyword>
  <keyword>Ablation</keyword>
  <keyword>Percutaneous biopsy</keyword>
  <keyword>Shear wave elastography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02967198
org study id: 1508-099-695
nct id: NCT02967198
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether fusion technique of preradiofrequency
      ablation (RFA) or percutaneous liver biopsy cross-sectional imaging (CT or MR) and real-time
      ultrasonography would improve feasibility of RFA or liver biopsy in patients with liver tumor
      in comparison with ultrasonography guidance alone. And assessment of a new point shear-wave
      elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver
      stiffness (LS) with another pSWE technique (ARFI).
RFA is one of commonly used local therapies for primary or secondary liver tumors. And
      percutaneous liver biopsy is very important technique to confirm the diagnosis of focal
      hepatic lesion whether benign or malignancy.

      For successful and safe procedure, safe access route and lesion visibility are essential ,
      and the conditions are usually evaluated on pre-procedure planning ultrasonography (USG).
      However, these procedure is sometimes aborted due to limited sonic window of various cause
      and challenging identification of small isoechoic tumors or hepatocellular carcinomas among
      dysplastic nodules . Therefore, precise targeting and assuring safe route would be of
      clinical importance. In this preliminary study, investigators attempted to determine US and
      CT/MR fusion technique would be able to improve RFA or liver biopsy feasibility in patients
      with liver tumors in comparison with conventional US alone technique.

      In addition, to assess intra- and inter-observer reproducibility of a new point shear-wave
      elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver
      stiffness (LS) with another pSWE technique (ARFI).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: RFA or biopsy feasibility rates on planning USG with/without fusion CT/MR and US
time frame: 10 minutes after finishing planning USG
description: comparison of rates of RFA feasibility on conventional planning USG and on fusion planning USG
measure: Assessment of a new point shear-wave elastography method (pSWE, S-shear wave)
time frame: 10 minutes after finishing planning USG
description: To assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).
measure: Rate of tumor visibility on planning USG with/without fusion technique
time frame: 10 minutes after finishing planning USG
description: comparison of tumor visibility (or detection) rates on planning USG on conventional planning USG and fusion planning USG
measure: Number of patients with safety access route on planning USG with/without fusion technique
time frame: 10 minutes after finishing planning USG
description: comparison of number of patients with presence/absence of safety access route, and the on two planning USGs
arm group label: CT/US fusion
arm group type: Experimental
description: patients undergo routine conventional feasibility planning ultrasound, and clinical decision of percutaneous liver biopsy or RFA feasibility is made based on conventional planning ultrasound. Then additional planning ultrasound using CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging.
intervention type: Device
intervention name: CT/US fusion
description: Fusion of pre-procedure cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.
arm group label: CT/US fusion
intervention type: Device
intervention name: ultrasound shear wave elastography
description: ultrasound shear wave elastography is performed in S-shear wave scanner according to guidelines of ultrasound elastography.
arm group label: CT/US fusion
other name: S-shear wave
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Liver Cirrhosis
sharing ipd: No