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/NCT05998720</url>
    </required_header>
    <id_info>
      <org_study_id>ZDWY.FSK.025</org_study_id>
      <nct_id>NCT05998720</nct_id>
    </id_info>
    <brief_title>Application of New Magnetic Resonance UTE Technique in Hip Joint Lesions</brief_title>
    <official_title>Application of New Magnetic Resonance Technique-UTE in Hip Joint Lesions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fifth Affiliated Hospital, Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fifth Affiliated Hospital, Sun Yat-Sen University</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>
        Explore the imaging and quantitative monitoring of hip bone, cartilage and ligament by&#xD;
        magnetic resonance UTE technology, combined with QCT and DXA technology, to provide a more&#xD;
        accurate basis for clinical evaluation and treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Osteoporosis is a systemic bone metabolism-related disease characterized by decreased bone&#xD;
        mass per unit volume, increased bone fragility, decreased bone density, thinning of the bone&#xD;
        cortex and changes in bone microstructure. It often occurs in the lumbar spine and hip joint.&#xD;
        Femoral neck fracture is a common complication of hip osteoporosis, which seriously affects&#xD;
        people's quality of life. UTE technology can clearly image and quantify human cortical bone&#xD;
        and cancellous bone, and advanced UTE technology such as STAIR-UTE and UTE-MT have made some&#xD;
        progress in the field of osteoporosis. The purpose of this study was to explore UTE&#xD;
        technology for imaging and quantitative study of cortical bone, cancellous bone and cartilage&#xD;
        of hip joint, and to find more accurate imaging methods for clinical evaluation of hip&#xD;
        osteoporosis and other diseases.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">June 13, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 13, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>proton density fat fraction (PDFF)</measure>
      <time_frame>Baseline (before surgery)</time_frame>
      <description>Magnetic resonance proton density fat fraction</description>
    </primary_outcome>
    <primary_outcome>
      <measure>T2 relaxation rate</measure>
      <time_frame>Baseline (before surgery)</time_frame>
      <description>R2*</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Magnetization Transfer Ratio (MTR)</measure>
      <time_frame>Baseline (before surgery)</time_frame>
      <description>magnetization transfer ratio</description>
    </primary_outcome>
    <primary_outcome>
      <measure>T1rho</measure>
      <time_frame>Baseline (before surgery)</time_frame>
      <description>spin-lattice relaxation in the rotation ame</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Subjective rating values</measure>
      <time_frame>Baseline (before surgery)</time_frame>
      <description>rating values</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Hip Disease</condition>
    <arm_group>
      <arm_group_label>normal group</arm_group_label>
      <description>There are no lesions on the hip.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>abnormal group</arm_group_label>
      <description>There are some lesions on the hip.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who meet the inclusion criteria&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with past or suspected osteoporosis and bone loss;&#xD;
  &#xD;
            2. Patients with previous femoral neck fracture;&#xD;
  &#xD;
            3. Patients with avascular necrosis of femoral head;&#xD;
  &#xD;
            4. Hip osteoarthritis patients.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with metal implants in corresponding parts;&#xD;
  &#xD;
            2. Claustrophobic.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shaolin Li</last_name>
      <role>Study Director</role>
      <affiliation>Fifth Affiliated Hospital, Sun Yat-Sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiaojun Chen</last_name>
      <phone>+8615820587112</phone>
      <email>422175400@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Radiography department</name>
        <address>
          <city>Zhuhai</city>
          <state>Guangdong</state>
          <zip>519000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaojun Chen</last_name>
        <phone>+8615820587112</phone>
        <email>422175400@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05998720
  org study id: ZDWY.FSK.025
  nct id: NCT05998720
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Explore the imaging and quantitative monitoring of hip bone, cartilage and ligament by
        magnetic resonance UTE technology, combined with QCT and DXA technology, to provide a more
        accurate basis for clinical evaluation and treatment.
  Osteoporosis is a systemic bone metabolism-related disease characterized by decreased bone
        mass per unit volume, increased bone fragility, decreased bone density, thinning of the bone
        cortex and changes in bone microstructure. It often occurs in the lumbar spine and hip joint.
        Femoral neck fracture is a common complication of hip osteoporosis, which seriously affects
        people's quality of life. UTE technology can clearly image and quantify human cortical bone
        and cancellous bone, and advanced UTE technology such as STAIR-UTE and UTE-MT have made some
        progress in the field of osteoporosis. The purpose of this study was to explore UTE
        technology for imaging and quantitative study of cortical bone, cancellous bone and cartilage
        of hip joint, and to find more accurate imaging methods for clinical evaluation of hip
        osteoporosis and other diseases.
  observational model: Cohort
  time perspective: Prospective
  measure: proton density fat fraction (PDFF)
  time frame: Baseline (before surgery)
  description: Magnetic resonance proton density fat fraction
  measure: T2 relaxation rate
  time frame: Baseline (before surgery)
  description: R2*
  measure: Magnetization Transfer Ratio (MTR)
  time frame: Baseline (before surgery)
  description: magnetization transfer ratio
  measure: T1rho
  time frame: Baseline (before surgery)
  description: spin-lattice relaxation in the rotation ame
  measure: Subjective rating values
  time frame: Baseline (before surgery)
  description: rating values
  arm group label: normal group
  description: There are no lesions on the hip.
  arm group label: abnormal group
  description: There are some lesions on the hip.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Shaolin Li
  role: Study Director
  affiliation: Fifth Affiliated Hospital, Sun Yat-Sen University
  last name: Xiaojun Chen
  phone: +8615820587112
  email: 422175400@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No