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/NCT06010290</url>
    </required_header>
    <id_info>
      <org_study_id>MAO-B PET/CT STUDY</org_study_id>
      <nct_id>NCT06010290</nct_id>
    </id_info>
    <brief_title>The Novel 18F-labeled MAO-B PET Tracer Study in Parkinsonism Patients</brief_title>
    <official_title>The Novel 18F-labeled MAO-B PET/CT Imaging on Parkinsonism Patients of Chinese Population: a Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Anhui Provincial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Anhui Provincial 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>
        This study mainly aims to prospectively evaluate the changes of reactive astrogliosis in&#xD;
        Parkinsonism patients of Chinese population by the novel 18F-labeled MAO-B PET tracer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        18F-SMBT-1, the novel 18F-labeled MAO-B PET tracer, was evaluated reactive astrogliosis in&#xD;
        Alzheimer's disease successfully. In this prospective study, we assess the changes of&#xD;
        reactive astrocytes in cerebral gray matter and white matter on Parkinson's disease by&#xD;
        18F-SMBT-1 PET/CT imaging among Chinese population.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 30, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Standard uptake value ratio (SUVR)</measure>
      <time_frame>60 days</time_frame>
      <description>Standard uptake value ratio of 18F-SMBT-1, 18F-FP-CIT and 18F-FDG in the key cerebral regions using the cerebellar cortex or subcortical white matter as a reference region</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical parameters</measure>
      <time_frame>60 days</time_frame>
      <description>Clinical parameters include sex, age, Hoehn-Yahr Stage, and Unified Parkinson's disease rating scale (UPDRS).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation coefficient 1</measure>
      <time_frame>60 days</time_frame>
      <description>Correlation analysis of SUVR between 18F-SMBT-1, 18F-FP-CIT and 18F-FDG in the key cerebral regions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation coefficient 2</measure>
      <time_frame>60 days</time_frame>
      <description>Correlation analysis between SUVR of 18F-SMBT-1 PET/CT in the key cerebral regions and clinical parameters.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Parkinsonism patients</arm_group_label>
      <description>This group/cohort comprises clinically diagnosed as Parkinsonism, including Parkinson's disease and atypical Parkinsonism syndromes, and each participant is injected 18F-SMBT-1 (185-370Mbq) and underwent PET/CT scanning within 50-70 min after injection.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Health control</arm_group_label>
      <description>Each participant is injected 18F-SMBT-1 (185-370Mbq) and underwent PET/CT scanning within 50-70 min after injection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>18F-SMBT-1</intervention_name>
      <description>Each participant receives intravenous injection of 18F-SMBT-1, and undergo PET/CT imaging within the special time. 18F-FP-CIT and 18F-FDG PET/CT are used to assess the change of cerebral dopamine transporters and glucose metabolism for auxiliary diagnosis.</description>
      <arm_group_label>Health control</arm_group_label>
      <arm_group_label>Parkinsonism patients</arm_group_label>
      <other_name>18F-FP-CIT</other_name>
      <other_name>18F-FDG</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study population are recruited from the Department of Neurology of the First Affiliated&#xD;
          Hospital of University of Science and Technology of China (USTC).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged from 40 to 90 years old.&#xD;
  &#xD;
            -  Clinically diagnosed as Parkinsonism, including Parkinson's disease and atypical&#xD;
               Parkinsonism syndromes.&#xD;
  &#xD;
            -  Can cooperate with 18F-FDG PET/CT, 18F-FP-CIT PET/CT and 3D T1-weighted structural MR&#xD;
               scans.&#xD;
  &#xD;
            -  Complete clinical data, including modified Hoehn and Yahr staging scale and the&#xD;
               Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Cannot cooperate with PET/CT or MR examination.&#xD;
  &#xD;
            -  Associated with brain diseases such as stroke, brain trauma, brain tumor, and cranial&#xD;
               surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Qiang Xie, MD</last_name>
      <role>Study Chair</role>
      <affiliation>The First Affiliated Hospital of China University of Science and Technology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Qiang Xie, MD</last_name>
      <phone>+8613721108043</phone>
      <email>xieqiang1980@ustc.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Affiliated Hospital of China University of Science and Technology</name>
        <address>
          <city>Hefei</city>
          <state>Anhui</state>
          <zip>230000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qiang Xie, MD</last_name>
        <phone>+8613721108043</phone>
        <email>xieqiang1980@ustc.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>November 2022</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 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 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>PET/CT</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Parkinsonian Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fluorodeoxyglucose F18</mesh_term>
    </intervention_browse>
    <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/NCT06010290
  org study id: MAO-B PET/CT STUDY
  nct id: NCT06010290
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study mainly aims to prospectively evaluate the changes of reactive astrogliosis in
        Parkinsonism patients of Chinese population by the novel 18F-labeled MAO-B PET tracer.
  18F-SMBT-1, the novel 18F-labeled MAO-B PET tracer, was evaluated reactive astrogliosis in
        Alzheimer's disease successfully. In this prospective study, we assess the changes of
        reactive astrocytes in cerebral gray matter and white matter on Parkinson's disease by
        18F-SMBT-1 PET/CT imaging among Chinese population.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Standard uptake value ratio (SUVR)
  time frame: 60 days
  description: Standard uptake value ratio of 18F-SMBT-1, 18F-FP-CIT and 18F-FDG in the key cerebral regions using the cerebellar cortex or subcortical white matter as a reference region
  measure: Clinical parameters
  time frame: 60 days
  description: Clinical parameters include sex, age, Hoehn-Yahr Stage, and Unified Parkinson's disease rating scale (UPDRS).
  measure: Correlation coefficient 1
  time frame: 60 days
  description: Correlation analysis of SUVR between 18F-SMBT-1, 18F-FP-CIT and 18F-FDG in the key cerebral regions.
  measure: Correlation coefficient 2
  time frame: 60 days
  description: Correlation analysis between SUVR of 18F-SMBT-1 PET/CT in the key cerebral regions and clinical parameters.
  arm group label: Parkinsonism patients
  description: This group/cohort comprises clinically diagnosed as Parkinsonism, including Parkinson's disease and atypical Parkinsonism syndromes, and each participant is injected 18F-SMBT-1 (185-370Mbq) and underwent PET/CT scanning within 50-70 min after injection.
  arm group label: Health control
  description: Each participant is injected 18F-SMBT-1 (185-370Mbq) and underwent PET/CT scanning within 50-70 min after injection.
  intervention type: Drug
  intervention name: 18F-SMBT-1
  description: Each participant receives intravenous injection of 18F-SMBT-1, and undergo PET/CT imaging within the special time. 18F-FP-CIT and 18F-FDG PET/CT are used to assess the change of cerebral dopamine transporters and glucose metabolism for auxiliary diagnosis.
  arm group label: Health control
  arm group label: Parkinsonism patients
  other name: 18F-FP-CIT
  other name: 18F-FDG
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 90 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Qiang Xie, MD
  role: Study Chair
  affiliation: The First Affiliated Hospital of China University of Science and Technology
  last name: Qiang Xie, MD
  phone: +8613721108043
  email: xieqiang1980@ustc.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  mesh term: Parkinsonian Disorders
  mesh term: Fluorodeoxyglucose F18
  sharing ipd: No