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/NCT05963035</url>
    </required_header>
    <id_info>
      <org_study_id>XLan-0409</org_study_id>
      <nct_id>NCT05963035</nct_id>
    </id_info>
    <brief_title>Clinical Application of 18F-PFPN PET Imaging in Diagnosis and Staging of Clear Cell Sarcoma of Soft Tissue</brief_title>
    <official_title>Clinical Application of 18F-PFPN PET Imaging in Diagnosis and Staging of Clear Cell Sarcoma of Soft Tissue</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wuhan Union Hospital, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wuhan Union Hospital, China</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>
        This study is a prospective monocentric study aimed to evaluate the diagnosis and staging&#xD;
        value of 18F-PFPN PET in clear cell sarcoma of soft tissue. Patients with clinically&#xD;
        suspected or confirmed clear cell sarcoma of soft tissue will be recruited and 18F-PFPN&#xD;
        PET/MR imaging will be performed. PET/CT imaging will be performed in patients with&#xD;
        contraindications to MR. Additionally, to compare the diagnostic efficacy with the&#xD;
        traditional imaging agent 18F-FDG, patients will also undergo 18F-FDG PET imaging, and the&#xD;
        two imaging intervals will be completed two days apart. The general information, clinical&#xD;
        data, 18F-PFPN and 18F-FDG PET/MR or PET/CT imaging results and other imaging data of the&#xD;
        patients will be collected. The histopathology of the biopsy or surgical specimen, follow-up&#xD;
        and other imaging examinations will be taken as evaluation references. This study plans to&#xD;
        set the sample size as 10 cases.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Clear cell sarcoma of soft tissue is a rare malignancy derived from neural crest cells that&#xD;
        contain melanin and/or melanin precursors. Melanin is an important target for the diagnosis&#xD;
        of clear cell sarcoma of soft tissue. 18F-PFPN, a highly specific melanin-targeting positron&#xD;
        probe, has been proven to have excellent pharmacokinetic properties and good biological&#xD;
        safety, and can sensitively detect tiny melanin-containing lesions. Therefore, 18F-PFPN PET&#xD;
        imaging is expected to be used in diagnosing and staging clear cell sarcoma of soft tissue.&#xD;
  &#xD;
        This study was designed as a prospective study to explore the diagnosis and staging value of&#xD;
        18F-PFPN PET in clear cell sarcoma of soft tissue. In this study, patients with clinically&#xD;
        suspected or confirmed clear cell sarcoma of soft tissue will be recruited to undergo&#xD;
        18F-PFPN PET/MR imaging. PET/CT imaging will be performed in patients with contraindications&#xD;
        to MR. The general information, clinical data, imaging data and histopathology results of&#xD;
        patients will be collected. The efficiency of diagnosis and staging of 18F-PFPN was evaluated&#xD;
        by comparing the gold standard pathological diagnosis and the general metabolic imaging agent&#xD;
        18F-FDG.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 21, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Sensitivity and specificity of 18F-PFPN PET for diagnosis and staging of clear cell sarcoma of soft tissue</measure>
      <time_frame>1 years</time_frame>
      <description>18F-PFPN and 18F-FDG PET/MR or PET/CT images will be analyzed by at least 2 physicians experienced in nuclear medicine and radiology. The general information, clinical, histopathological and imaging data of patients will be collected and analyzed to calculate the sensitivity and specificity of 18F-PFPN for diagnosis and staging in clear cell sarcoma of soft tissue.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Clear Cell Sarcoma of Soft Tissue</condition>
    <arm_group>
      <arm_group_label>18F-PFPN PET</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A positron probe for the targeted melanin</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>18F-PFPN</intervention_name>
      <description>For patients clinically suspected or confirmed clear cell sarcoma of soft tissue, integrated PET/MR or PET/CT imaging will be performed using targeted melanin-specific imaging agent 18F-PFPN. Meanwhile, multiple parameters will be compared with the general imaging agent 18F-FDG.</description>
      <arm_group_label>18F-PFPN PET</arm_group_label>
      <other_name>18F-PEG3-FPN</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients (age 18 years or above), regardless of gender;&#xD;
  &#xD;
            -  Patients with clinically suspected or confirmed clear cell sarcoma of soft tissue&#xD;
               (supporting evidence including visual examination, MRI, CT, ultrasound, and&#xD;
               histopathological examination, etc.) ;&#xD;
  &#xD;
            -  Patients who agree to undergo both 18F-PFPN and 18F-FDG PET imaging.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Acute systemic diseases and electrolyte disturbances;&#xD;
  &#xD;
            -  Patients who plan to get pregnant within six months or are pregnant or breastfeeding;&#xD;
  &#xD;
            -  The patient or his/her legal representative is unable or unwilling to sign the&#xD;
               informed consent.&#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>Xiaoli Lan</last_name>
      <role>Study Director</role>
      <affiliation>Wuhan Union Hospital, China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiaoli Lan</last_name>
      <phone>0086-027-83692633</phone>
      <email>lxl730724@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>China, Hubei Province</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430022</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaoli Lan</last_name>
        <phone>+86-027-83692633</phone>
        <email>lxl730724@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sarcoma</mesh_term>
      <mesh_term>Sarcoma, Clear Cell</mesh_term>
    </condition_browse>
    <!-- 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/NCT05963035
  org study id: XLan-0409
  nct id: NCT05963035
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a prospective monocentric study aimed to evaluate the diagnosis and staging
        value of 18F-PFPN PET in clear cell sarcoma of soft tissue. Patients with clinically
        suspected or confirmed clear cell sarcoma of soft tissue will be recruited and 18F-PFPN
        PET/MR imaging will be performed. PET/CT imaging will be performed in patients with
        contraindications to MR. Additionally, to compare the diagnostic efficacy with the
        traditional imaging agent 18F-FDG, patients will also undergo 18F-FDG PET imaging, and the
        two imaging intervals will be completed two days apart. The general information, clinical
        data, 18F-PFPN and 18F-FDG PET/MR or PET/CT imaging results and other imaging data of the
        patients will be collected. The histopathology of the biopsy or surgical specimen, follow-up
        and other imaging examinations will be taken as evaluation references. This study plans to
        set the sample size as 10 cases.
  Clear cell sarcoma of soft tissue is a rare malignancy derived from neural crest cells that
        contain melanin and/or melanin precursors. Melanin is an important target for the diagnosis
        of clear cell sarcoma of soft tissue. 18F-PFPN, a highly specific melanin-targeting positron
        probe, has been proven to have excellent pharmacokinetic properties and good biological
        safety, and can sensitively detect tiny melanin-containing lesions. Therefore, 18F-PFPN PET
        imaging is expected to be used in diagnosing and staging clear cell sarcoma of soft tissue.
  
        This study was designed as a prospective study to explore the diagnosis and staging value of
        18F-PFPN PET in clear cell sarcoma of soft tissue. In this study, patients with clinically
        suspected or confirmed clear cell sarcoma of soft tissue will be recruited to undergo
        18F-PFPN PET/MR imaging. PET/CT imaging will be performed in patients with contraindications
        to MR. The general information, clinical data, imaging data and histopathology results of
        patients will be collected. The efficiency of diagnosis and staging of 18F-PFPN was evaluated
        by comparing the gold standard pathological diagnosis and the general metabolic imaging agent
        18F-FDG.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Sensitivity and specificity of 18F-PFPN PET for diagnosis and staging of clear cell sarcoma of soft tissue
  time frame: 1 years
  description: 18F-PFPN and 18F-FDG PET/MR or PET/CT images will be analyzed by at least 2 physicians experienced in nuclear medicine and radiology. The general information, clinical, histopathological and imaging data of patients will be collected and analyzed to calculate the sensitivity and specificity of 18F-PFPN for diagnosis and staging in clear cell sarcoma of soft tissue.
  arm group label: 18F-PFPN PET
  arm group type: Experimental
  description: A positron probe for the targeted melanin
  intervention type: Drug
  intervention name: 18F-PFPN
  description: For patients clinically suspected or confirmed clear cell sarcoma of soft tissue, integrated PET/MR or PET/CT imaging will be performed using targeted melanin-specific imaging agent 18F-PFPN. Meanwhile, multiple parameters will be compared with the general imaging agent 18F-FDG.
  arm group label: 18F-PFPN PET
  other name: 18F-PEG3-FPN
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xiaoli Lan
  role: Study Director
  affiliation: Wuhan Union Hospital, China
  last name: Xiaoli Lan
  phone: 0086-027-83692633
  email: lxl730724@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Sarcoma
  mesh term: Sarcoma, Clear Cell