<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/NCT04487288</url>
  </required_header>
  <id_info>
    <org_study_id>H-2003-044-1108</org_study_id>
    <nct_id>NCT04487288</nct_id>
  </id_info>
  <brief_title>Added Value in Combined Use of Fusion Imaging and Contrast-enhanced Ultrasonography</brief_title>
  <official_title>Added Value in Combined Use of Fusion Imaging and Contrast-enhanced Ultrasonography Compared to Fusion Imaging Alone for Percutaneous Biopsies of Focal Liver Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Korean Liver Cancer Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      So far, there have been studies showing that the CEUS-grafted technique has added value in&#xD;
      biopsy and RFA, but no studies have compared the group using only fusion and the group using&#xD;
      CEUS+fusion. Therefore, the additional added value of CEUS will be evaluated by comparing the&#xD;
      two groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the rapid development of tumor markers and liver imaging, pathological confirmation&#xD;
      is still necessary for atypical liver lesions that do not meet imaging criteria. US guided&#xD;
      procedures are widely used as a method to identify focal lesions of the liver pathologically,&#xD;
      and these US guided procedures have no burden on the operation, can be easily accessed, and&#xD;
      have a lower cost than surgery. However, the frequency of pathological confirmation with this&#xD;
      US guided procedure remains at around 90%. In order to increase this probability, a technique&#xD;
      for fusion of liver CT/MRI and US has been widely used in recent years, and this allows&#xD;
      accurate targeting of small lesions through structures seen in CT and MR. Through the fusion&#xD;
      technique, the biopsy success rate for focal lesions can be increased to 94.4%. However,&#xD;
      there are many cases where lesions deeply located in patients with cirrhosis are invisible,&#xD;
      and biopsy is difficult only with fusion due to poor sonic window in patients with high BMI.&#xD;
      To this end, a technique called contrast-enhanced ultrasonography (CEUS), such as the fusion&#xD;
      technique, was added, which is a technique that can identify tumor vascularity in real-time&#xD;
      using second-generation contrast media. In recent studies, there are studies combining this&#xD;
      fusion technique and CEUS technique, and the success rate of these techniques varies from&#xD;
      87.6% to 97.5%. Although CEUS with fusion techniques are theoretically superior to fusion&#xD;
      only technique, the use of CEUS adds cost of contrast media and is limited in patients with&#xD;
      side effects on contrast media. . Also, there is no study comparing the two so far, and this&#xD;
      study intends to compare the technique combining CEUS and fusion and the technique using only&#xD;
      fusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2022</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biopsy yield rate</measure>
    <time_frame>about 2weeks</time_frame>
    <description>Yield rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>about 2days</time_frame>
    <description>Complication rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor visibility on B-mode US</measure>
    <time_frame>immediately</time_frame>
    <description>Tumor visibility on B-mode US which divided into 1 (no visualization), 2 (poorly visible), 3 (indistinct), and 4 (clearly visible)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of safety access routes to avoid complication</measure>
    <time_frame>Time: immediately</time_frame>
    <description>Evaluate whether the needle has a safety route that can prevent complication by avoiding vessels or bile ducts in the liver.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor vascularity on CEUS</measure>
    <time_frame>Time: immediately</time_frame>
    <description>The tumor vascularity is evaluated by CEUS (hyper, iso, hypo vascularity on arterial phase), and compared to contrast enhancement on the CT or MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective evaluation on the success of the procedure</measure>
    <time_frame>immediately</time_frame>
    <description>Immediately after the procedure, the reliability of appropriate tissue collection for the viable portion is determined and recorded. A score of 3-4 means that operator is expecting a successful enough tissue harvest, and a score of 1-2 means operator is not expecting proper tissue collection.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Contrast Media, Liver, Biopsy, Fusion</condition>
  <arm_group>
    <arm_group_label>CEUS with fusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Control group: The historic cohort is used to compare the results of the biopsy using fusion only technique from 2013 to 2019.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SONAZOID</intervention_name>
    <description>CEUS using SONAZOID with fusion technique</description>
    <arm_group_label>CEUS with fusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for ultrasound biopsy to confirm local liver lesions&#xD;
&#xD;
          -  Adults over 18&#xD;
&#xD;
          -  Patients who underwent multi-phasic liver CT or MRI within 6 weeks prior to the&#xD;
             procedure&#xD;
&#xD;
          -  Patients who understand and agree to the explanation and consent form and submit the&#xD;
             consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-adaptive patients with ultrasound contrast agents (eg acute respiratory failure,&#xD;
             heart disease, egg allergy, pregnant women, lactating women)&#xD;
&#xD;
          -  Those who have difficulty obtaining proper liver ultrasound images A. Patient&#xD;
             cooperation is not possible B. If it is difficult to obtain an image that is&#xD;
             appropriate for the researcher's judgment (atrophy of the right lobe of the liver, a&#xD;
             bowel is located between the liver and the abdominal wall, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeong Min Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital, Radiology department</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>SAE JIN PARK, MD</last_name>
    <phone>+82-2072-3107</phone>
    <phone_ext>3107</phone_ext>
    <email>psjko05@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jeong Min Lee, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jeong Min Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT04487288
org study id: H-2003-044-1108
nct id: NCT04487288
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
So far, there have been studies showing that the CEUS-grafted technique has added value in
      biopsy and RFA, but no studies have compared the group using only fusion and the group using
      CEUS+fusion. Therefore, the additional added value of CEUS will be evaluated by comparing the
      two groups.
Despite the rapid development of tumor markers and liver imaging, pathological confirmation
      is still necessary for atypical liver lesions that do not meet imaging criteria. US guided
      procedures are widely used as a method to identify focal lesions of the liver pathologically,
      and these US guided procedures have no burden on the operation, can be easily accessed, and
      have a lower cost than surgery. However, the frequency of pathological confirmation with this
      US guided procedure remains at around 90%. In order to increase this probability, a technique
      for fusion of liver CT/MRI and US has been widely used in recent years, and this allows
      accurate targeting of small lesions through structures seen in CT and MR. Through the fusion
      technique, the biopsy success rate for focal lesions can be increased to 94.4%. However,
      there are many cases where lesions deeply located in patients with cirrhosis are invisible,
      and biopsy is difficult only with fusion due to poor sonic window in patients with high BMI.
      To this end, a technique called contrast-enhanced ultrasonography (CEUS), such as the fusion
      technique, was added, which is a technique that can identify tumor vascularity in real-time
      using second-generation contrast media. In recent studies, there are studies combining this
      fusion technique and CEUS technique, and the success rate of these techniques varies from
      87.6% to 97.5%. Although CEUS with fusion techniques are theoretically superior to fusion
      only technique, the use of CEUS adds cost of contrast media and is limited in patients with
      side effects on contrast media. . Also, there is no study comparing the two so far, and this
      study intends to compare the technique combining CEUS and fusion and the technique using only
      fusion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Biopsy yield rate
time frame: about 2weeks
description: Yield rate
measure: Complication rate
time frame: about 2days
description: Complication rate
measure: Tumor visibility on B-mode US
time frame: immediately
description: Tumor visibility on B-mode US which divided into 1 (no visualization), 2 (poorly visible), 3 (indistinct), and 4 (clearly visible)
measure: Evaluation of safety access routes to avoid complication
time frame: Time: immediately
description: Evaluate whether the needle has a safety route that can prevent complication by avoiding vessels or bile ducts in the liver.
measure: Tumor vascularity on CEUS
time frame: Time: immediately
description: The tumor vascularity is evaluated by CEUS (hyper, iso, hypo vascularity on arterial phase), and compared to contrast enhancement on the CT or MRI
measure: Subjective evaluation on the success of the procedure
time frame: immediately
description: Immediately after the procedure, the reliability of appropriate tissue collection for the viable portion is determined and recorded. A score of 3-4 means that operator is expecting a successful enough tissue harvest, and a score of 1-2 means operator is not expecting proper tissue collection.
arm group label: CEUS with fusion
arm group type: Experimental
description: Control group: The historic cohort is used to compare the results of the biopsy using fusion only technique from 2013 to 2019.
intervention type: Diagnostic Test
intervention name: SONAZOID
description: CEUS using SONAZOID with fusion technique
arm group label: CEUS with fusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jeong Min Lee, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital, Radiology department
last name: SAE JIN PARK, MD
phone: +82-2072-3107
phone ext: 3107
email: psjko05@gmail.com
facility: 
status: Recruiting
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jeong Min Lee
investigator title: Professor
sharing ipd: No