xml: <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/NCT06018142</url>
    </required_header>
    <id_info>
      <org_study_id>S2023-408-01</org_study_id>
      <nct_id>NCT06018142</nct_id>
    </id_info>
    <brief_title>Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid Tumors</brief_title>
    <official_title>Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese PLA General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chinese PLA General Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        It has well accepted that tumor angiogenesis present aberrant vascular architecture and&#xD;
        functional abnormalities, which is associated with tumorigenesis, tumor propagation and&#xD;
        progression. By locating, separating and tracking microbubbles, the recently introduced and&#xD;
        upgraded Ultrasound Localization Microscopy (ULM) surpassed classical wave diffraction limit.&#xD;
        However, the acquisition of structural and functional parameters of microcirculation in vivo&#xD;
        for ULM is still confined by the compromise between the resolution and penetration depth. The&#xD;
        relatively long acquisition time induced the difficulty of motion correction potentially,&#xD;
        which hampers the preclinical to clinical application in organs with distinct tissue motion&#xD;
        such as the liver. Therefore, we take the lead in studying human liver lesion&#xD;
        microvasculature, which remains a challenge for noninvasive, quantitative and functional&#xD;
        intravital imaging especially due to its deep-seated location and strong motion. We developed&#xD;
        a Super-resolution Ultrasound (SR-US) imaging technique based on ULM to assess its&#xD;
        feasibility of visualizing and quantifying microvasculature in human organs.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, 7 indexes were obtained by ultrasonic acquisition. These 7 indicators are used&#xD;
        to describe and evaluate the microvessels in the tumor, so as to achieve the early&#xD;
        identification and diagnosis of the tumor, and to monitor the growth of the tumor for a long&#xD;
        time and evaluate the treatment of the tumor. This is not available with other ultrasound&#xD;
        devices.&#xD;
  &#xD;
        Based on contrast-enhanced ultrasound, this technology can provide information of smaller&#xD;
        blood vessels, which will certainly contribute to the early diagnosis and real-time&#xD;
        evaluation of solid tumors during treatment, and play an important role in clinical&#xD;
        application.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2022</start_date>
    <completion_date type="Anticipated">February 28, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 28, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Month</target_duration>
    <primary_outcome>
      <measure>Perfusion index</measure>
      <time_frame>30 minutes</time_frame>
      <description>The product of the average speed of microbubbles in region of interest (ROI) and the ROI area</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vessel diameter</measure>
      <time_frame>30 minutes</time_frame>
      <description>To describe the diameters of the tiniest blood vessels that can be explored</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vessel density</measure>
      <time_frame>30 minutes</time_frame>
      <description>To describe the ratio of the number of blood vessels in the tumor to the cross-sectional area of the tumor</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vessel density ratio</measure>
      <time_frame>30 minutes</time_frame>
      <description>The ratio of blood vessel density between the core and peripheral areas of the tumor</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean flow velocity</measure>
      <time_frame>30 minutes</time_frame>
      <description>The average velocity in the region of interest</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Distance metric</measure>
      <time_frame>30 minutes</time_frame>
      <description>The ratio of the total length of the curve path to the straight line distance from the beginning to the end of the curve</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perfusion ratio</measure>
      <time_frame>30 minutes</time_frame>
      <description>Perfusion ratio of tumor core to peripheral area</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Neoplasms, Liver</condition>
    <condition>Neoplasms Malignant</condition>
    <condition>Neoplasm Metastasis</condition>
    <condition>Ultrasound</condition>
    <condition>Microvessels</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who are eligible for the inclusion criteria as well as the exclusion criteria are&#xD;
          enrolled in this study to obtain their clinical information.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age over 18 years old, gender unlimited;&#xD;
  &#xD;
            2. Patients with solid organ tumors with a maximum diameter &gt; 1cm;&#xD;
  &#xD;
            3. No contraindications with contrast ultrasound agents;&#xD;
  &#xD;
            4. It can improve the pathological results of the tumor or the diagnostic results&#xD;
               supported by other relevant imaging tests.&#xD;
  &#xD;
            5. Patients can understand the purpose of the examination, voluntarily participate and&#xD;
               sign the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The subject is known to be allergic to any component of the contrast agent Sonovue;&#xD;
  &#xD;
            2. Lesions were diffuse or borderless on contrast ultrasound;&#xD;
  &#xD;
            3. Patients who underwent previous anti-angiogenesis and chemotherapy, or other local&#xD;
               treatment of the tumor;&#xD;
  &#xD;
            4. Poor image display or deep position in conventional ultrasound evaluation (&lt;10 cm from&#xD;
               skin),&#xD;
  &#xD;
            5. The researchers determined that there were any other factors that were not suitable&#xD;
               for inclusion or affected participants' participation in the study&#xD;
  &#xD;
            6. Patients with severe heart disease or lung disease;&#xD;
  &#xD;
            7. Patients who are pregnant, may be pregnant or breastfeeding;&#xD;
  &#xD;
            8. No enhanced MRI or enhanced CT results can be obtained;&#xD;
  &#xD;
            9. The investigator considers the subjects unfit to participate in this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ping Liang, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chinese PLA General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jie Yu, Doctor</last_name>
      <phone>010-66937981</phone>
      <email>liangping301@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Interventional Ultrasound of Chinese PLAGH</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chaonan Chen</last_name>
        <phone>+8613693315104</phone>
        <email>chenchaonan130@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Qianqian Zeng</last_name>
        <phone>+8617677573551</phone>
        <email>tsengqianqian@qq.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
      <investigator_full_name>Ping Liang</investigator_full_name>
      <investigator_title>Chief physician</investigator_title>
    </responsible_party>
    <keyword>super-resolution ultrasound imaging</keyword>
    <keyword>ultrasound</keyword>
    <keyword>solid tumor</keyword>
    <keyword>micro flow imaging</keyword>
    <keyword>Microvessels</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Neoplasm Metastasis</mesh_term>
      <mesh_term>Liver Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The reason we cannot provide individual participant data (IPD) is because the data we obtained from the super-resolution ultrasound images is not publicly available</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018142
  org study id: S2023-408-01
  nct id: NCT06018142
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  It has well accepted that tumor angiogenesis present aberrant vascular architecture and
        functional abnormalities, which is associated with tumorigenesis, tumor propagation and
        progression. By locating, separating and tracking microbubbles, the recently introduced and
        upgraded Ultrasound Localization Microscopy (ULM) surpassed classical wave diffraction limit.
        However, the acquisition of structural and functional parameters of microcirculation in vivo
        for ULM is still confined by the compromise between the resolution and penetration depth. The
        relatively long acquisition time induced the difficulty of motion correction potentially,
        which hampers the preclinical to clinical application in organs with distinct tissue motion
        such as the liver. Therefore, we take the lead in studying human liver lesion
        microvasculature, which remains a challenge for noninvasive, quantitative and functional
        intravital imaging especially due to its deep-seated location and strong motion. We developed
        a Super-resolution Ultrasound (SR-US) imaging technique based on ULM to assess its
        feasibility of visualizing and quantifying microvasculature in human organs.
  In this study, 7 indexes were obtained by ultrasonic acquisition. These 7 indicators are used
        to describe and evaluate the microvessels in the tumor, so as to achieve the early
        identification and diagnosis of the tumor, and to monitor the growth of the tumor for a long
        time and evaluate the treatment of the tumor. This is not available with other ultrasound
        devices.
  
        Based on contrast-enhanced ultrasound, this technology can provide information of smaller
        blood vessels, which will certainly contribute to the early diagnosis and real-time
        evaluation of solid tumors during treatment, and play an important role in clinical
        application.
  observational model: Case-Only
  time perspective: Prospective
  measure: Perfusion index
  time frame: 30 minutes
  description: The product of the average speed of microbubbles in region of interest (ROI) and the ROI area
  measure: Vessel diameter
  time frame: 30 minutes
  description: To describe the diameters of the tiniest blood vessels that can be explored
  measure: Vessel density
  time frame: 30 minutes
  description: To describe the ratio of the number of blood vessels in the tumor to the cross-sectional area of the tumor
  measure: Vessel density ratio
  time frame: 30 minutes
  description: The ratio of blood vessel density between the core and peripheral areas of the tumor
  measure: Mean flow velocity
  time frame: 30 minutes
  description: The average velocity in the region of interest
  measure: Distance metric
  time frame: 30 minutes
  description: The ratio of the total length of the curve path to the straight line distance from the beginning to the end of the curve
  measure: Perfusion ratio
  time frame: 30 minutes
  description: Perfusion ratio of tumor core to peripheral area
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Ping Liang, Doctor
  role: Principal Investigator
  affiliation: Chinese PLA General Hospital
  last name: Jie Yu, Doctor
  phone: 010-66937981
  email: liangping301@126.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Chinese PLA General Hospital
  investigator full name: Ping Liang
  investigator title: Chief physician
  mesh term: Neoplasms
  mesh term: Neoplasm Metastasis
  mesh term: Liver Neoplasms
  sharing ipd: No
  ipd description: The reason we cannot provide individual participant data (IPD) is because the data we obtained from the super-resolution ultrasound images is not publicly available