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/NCT06019975</url>
    </required_header>
    <id_info>
      <org_study_id>PEA</org_study_id>
      <nct_id>NCT06019975</nct_id>
    </id_info>
    <brief_title>FDG-PET in the Diagnosis of Autoimmune Encephalitis</brief_title>
    <acronym>PEA</acronym>
    <official_title>FDG-PET in the Diagnosis of Autoimmune Encephalitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Milano Bicocca</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Milano Bicocca</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>
        The goal of this retrospective observational study is to compare brain&#xD;
        fluorodeoxyglucose-positron emission tomography (FDG-PET) of patients with autoimmune&#xD;
        encephalitis, normal controls and patients with Alzheimer's disease (AD). The main question&#xD;
        it aims to answer is:&#xD;
  &#xD;
        •is there a specific pattern of brain metabolism in patients with autoimmune encephalitis&#xD;
        Participants data and images will be retrospectively collected from hospital records, and&#xD;
        FDG-PET images will be analyzed by means of statistical parametric mapping (SPM). Controls&#xD;
        will be selected from validated public databases.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>SPM analysis of brain metabolic pattern</measure>
      <time_frame>up to 6 months</time_frame>
      <description>Pattern of brain metabolism in patients with autoimmune encephalitis compared with healthy controls and patients with Alzheimer's disease, drawn from validated published databases</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sensitivity of basal ganglia hypermetabolism</measure>
      <time_frame>up to 6 months</time_frame>
      <description>Sensitivity of basal ganglia hypermetabolism for the diagnosis of autoimmune encephalitis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diagnostic delay</measure>
      <time_frame>up to 6 months</time_frame>
      <description>Comparison of diagnostic delay with and without FDG-PET</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Autoimmune Encephalitis</condition>
    <arm_group>
      <arm_group_label>Autoimmune Encephalitis patients</arm_group_label>
      <description>Patients with autoimmune encephalitis admitted to the centers, who underwent a brain FDG-PET during the course of their disease trajectory.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>FDG-PET</intervention_name>
      <description>Brain FDG-PET</description>
      <arm_group_label>Autoimmune Encephalitis patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with autoimmune encephalitis admitted to the recruiting centers&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of autoimmune encephalitis according to clinical criteria&#xD;
  &#xD;
            -  Brain magnetic resonance imaging performed between clinical presentation and treatment&#xD;
  &#xD;
            -  Cerebrospinal fluid analysis performed between clinical presentation and treatment&#xD;
  &#xD;
            -  Brain FDG-PET performed between clinical presentation and treatment&#xD;
  &#xD;
            -  Autoantibodies testing performed between clinical presentation and treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal to give consent for the study&#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>Simone Beretta, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Milano Bicocca</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Simone Beretta, MD, PhD</last_name>
      <phone>+390392333568</phone>
      <email>simone.beretta@unimib.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Federico Emanuele Pozzi, MD</last_name>
      <email>federicoemanuele.pozzi@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fondazione IRCCS San Gerardo dei Tintori</name>
        <address>
          <city>Monza</city>
          <state>Monza E Della Brianza</state>
          <zip>20900</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Simone Beretta, MD, PhD</last_name>
        <phone>+390392333568</phone>
        <email>simone.beretta@unimib.it</email>
      </contact>
      <investigator>
        <last_name>Simone Beretta, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Federico Emanuele Pozzi, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Fondazione IRCCS Istituto Neurologico &quot;Carlo Besta&quot;</name>
        <address>
          <city>Milano</city>
          <zip>20133</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Francesco Deleo, MD, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Francesco Deleo, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Andrea Stabile, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Ospedale San Paolo</name>
        <address>
          <city>Milano</city>
          <zip>20142</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Francesco Del Sole, MD, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Francesco Del Sole, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Autoimmune Encephalitis</keyword>
    <keyword>FDG-PET</keyword>
    <keyword>SPM</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Encephalitis</mesh_term>
      <mesh_term>Autoimmune Diseases of the Nervous System</mesh_term>
      <mesh_term>Hashimoto Disease</mesh_term>
    </condition_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/NCT06019975
  org study id: PEA
  nct id: NCT06019975
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this retrospective observational study is to compare brain
        fluorodeoxyglucose-positron emission tomography (FDG-PET) of patients with autoimmune
        encephalitis, normal controls and patients with Alzheimer's disease (AD). The main question
        it aims to answer is:
  
        •is there a specific pattern of brain metabolism in patients with autoimmune encephalitis
        Participants data and images will be retrospectively collected from hospital records, and
        FDG-PET images will be analyzed by means of statistical parametric mapping (SPM). Controls
        will be selected from validated public databases.
  observational model: Cohort
  time perspective: Retrospective
  measure: SPM analysis of brain metabolic pattern
  time frame: up to 6 months
  description: Pattern of brain metabolism in patients with autoimmune encephalitis compared with healthy controls and patients with Alzheimer's disease, drawn from validated published databases
  measure: Sensitivity of basal ganglia hypermetabolism
  time frame: up to 6 months
  description: Sensitivity of basal ganglia hypermetabolism for the diagnosis of autoimmune encephalitis
  measure: Diagnostic delay
  time frame: up to 6 months
  description: Comparison of diagnostic delay with and without FDG-PET
  arm group label: Autoimmune Encephalitis patients
  description: Patients with autoimmune encephalitis admitted to the centers, who underwent a brain FDG-PET during the course of their disease trajectory.
  intervention type: Diagnostic Test
  intervention name: FDG-PET
  description: Brain FDG-PET
  arm group label: Autoimmune Encephalitis patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Simone Beretta, MD, PhD
  role: Principal Investigator
  affiliation: University of Milano Bicocca
  last name: Simone Beretta, MD, PhD
  phone: +390392333568
  email: simone.beretta@unimib.it
  last name: Federico Emanuele Pozzi, MD
  email: federicoemanuele.pozzi@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Encephalitis
  mesh term: Autoimmune Diseases of the Nervous System
  mesh term: Hashimoto Disease
  sharing ipd: No