<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/NCT02985034</url>
  </required_header>
  <id_info>
    <org_study_id>SNUH-2010-1412</org_study_id>
    <nct_id>NCT02985034</nct_id>
  </id_info>
  <brief_title>Safety Margin Assessment After RFA Using the Registration of Pre-ablation MRI and Post-ablation CT</brief_title>
  <official_title>Prospective Evaluation of Local Tumor Progression After Radiofrequency Ablation of Hepatocellular Carcinoma: Effectiveness of Immediate Second-Look Evaluation Using Pre-RFA MRI and Post-RFA CT Registration</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>
      Magnetic resonance imaging (MRI) has been widely used for small liver lesion detection and&#xD;
      characterization. In patients who undergo RFA, MRI is often performed before RFA, whereas&#xD;
      immediate technical success is usually assessed by CT. Conventional visual assessment of two&#xD;
      modalities may be more challenging than being anticipated, because acquisition position,&#xD;
      respiration, and spatial resolution differ between the two. Therefore, the study purpose is&#xD;
      to evaluate the results of software-assisted ablative margin assessment using registration of&#xD;
      different pre-and post-RFA modalities compared with the conventional method of side-by-side&#xD;
      MRI-CT comparison in patients with HCCs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Local tumor progression (LTP)</measure>
    <time_frame>60 months</time_frame>
    <description>5-year-LTP rate in HCC between sufficient and insufficient ablative margin groups (according to visual assessment and registration software-assisted assessment)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>technique efficacy</measure>
    <time_frame>1 month after RFA</time_frame>
    <description>Rate of absence of viable tumor on 1-months follow-up CT scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>immediate technical success on visual assessment</measure>
    <time_frame>1 day after RFA</time_frame>
    <description>technical success of RFA on post-RFA CT using side-by-side comparison of pre-RFA MRI and post-RFA CT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>immediate technical success on registration-software assessment</measure>
    <time_frame>1 day after RFA</time_frame>
    <description>technical success of RFA on post-RFA CT using registration-software assessment between pre-RFA MRI and post-RFA CT</description>
  </secondary_outcome>
  <enrollment type="Actual">77</enrollment>
  <condition>HCC</condition>
  <condition>Liver Tumor</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RFA</intervention_name>
    <description>Radiofrequency ablation (RFA) is performed according to routine practice, and then safety margin is assessed by a) visual side-by-side comparison between pre-RFA MRI and post-RFA CT, and b) registration software for two modalities.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with liver tumor and referred to Radiology for RFA.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients (≥ 18 years) who were referred to our radiology department for liver tumor&#xD;
             RFA&#xD;
&#xD;
          -  patients who had liver MR images of sufficient quality for pre-RFA evaluation within&#xD;
             30 days before RFA&#xD;
&#xD;
          -  patients with 1-3 tumors (&lt;5 cm)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child-Pugh class C&#xD;
&#xD;
          -  any uncorrected coagulopathy&#xD;
&#xD;
          -  hypersensitivity to iodine or other reasons that prevented the performance of post-RFA&#xD;
             contrast-enhanced CT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeong Min Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <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>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 5, 2016</last_update_submitted>
  <last_update_submitted_qc>December 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</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>
  <keyword>HCC</keyword>
  <keyword>RFA</keyword>
  <keyword>Liver tumor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Neoplasms</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/NCT02985034
org study id: SNUH-2010-1412
nct id: NCT02985034
lead sponsor: 
has dmc: Yes
Magnetic resonance imaging (MRI) has been widely used for small liver lesion detection and
      characterization. In patients who undergo RFA, MRI is often performed before RFA, whereas
      immediate technical success is usually assessed by CT. Conventional visual assessment of two
      modalities may be more challenging than being anticipated, because acquisition position,
      respiration, and spatial resolution differ between the two. Therefore, the study purpose is
      to evaluate the results of software-assisted ablative margin assessment using registration of
      different pre-and post-RFA modalities compared with the conventional method of side-by-side
      MRI-CT comparison in patients with HCCs.
observational model: Cohort
time perspective: Prospective
measure: Local tumor progression (LTP)
time frame: 60 months
description: 5-year-LTP rate in HCC between sufficient and insufficient ablative margin groups (according to visual assessment and registration software-assisted assessment)
measure: technique efficacy
time frame: 1 month after RFA
description: Rate of absence of viable tumor on 1-months follow-up CT scan.
measure: immediate technical success on visual assessment
time frame: 1 day after RFA
description: technical success of RFA on post-RFA CT using side-by-side comparison of pre-RFA MRI and post-RFA CT
measure: immediate technical success on registration-software assessment
time frame: 1 day after RFA
description: technical success of RFA on post-RFA CT using registration-software assessment between pre-RFA MRI and post-RFA CT
intervention type: Procedure
intervention name: RFA
description: Radiofrequency ablation (RFA) is performed according to routine practice, and then safety margin is assessed by a) visual side-by-side comparison between pre-RFA MRI and post-RFA CT, and b) registration software for two modalities.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeong Min Lee, MD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jeong Min Lee
investigator title: Professor
mesh term: Liver Neoplasms
sharing ipd: No