<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/NCT01665196</url>
  </required_header>
  <id_info>
    <org_study_id>IgG4RD-PET</org_study_id>
    <nct_id>NCT01665196</nct_id>
  </id_info>
  <brief_title>18F-FDG PET/CT for IgG4-Related Disease</brief_title>
  <official_title>Evaluation of 18F-FDG PET/CT in Diagnosis and Response Assessment of Patients With IgG4-Related Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label study to investigate the diagnostic performance of 18F-FDG PET/CT&#xD;
      (positron emission tomography/computed tomography) in evaluation of patients with&#xD;
      IgG4-related disease. A single dose of 18F-FDG will be intravenously injected into patients&#xD;
      with IgG4-related disease before and after treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity&#xD;
      characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and&#xD;
      elevated serum IgG4 concentration. The most important feature of IgG4-RD is chronic&#xD;
      inflammation with multiple organ involvement. However, some organ involvements are difficult&#xD;
      to find by ultrasound, CT or MRI.&#xD;
&#xD;
      18F-FDG PET/CT is a sensitive imaging tool for inflammation. In this study, PET/CT were&#xD;
      performed in patients with IgG4-RD both before and after glucocorticoid treatment by a single&#xD;
      dose of 18F-FDG. Visual and semiquantitative method will be employed to assess the PET/CT&#xD;
      images. The PET/CT image data will be used to establish a diagnostic model as well as&#xD;
      assessment criteria for response evaluation of IgG4-RD treatments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Early Phase 1</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>Visual analysis of organ involvement and treatment response of the IgG4-RD patients.</measure>
    <time_frame>1 year</time_frame>
    <description>Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. The 18F-FDG PET/CT pattern of IgG4-RG will be extracted and summarized. The response to anti-immune treatment will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Semiquantitative measurement of lesion metabolism and treatment response of the IgG4-RD patients.</measure>
    <time_frame>1 year</time_frame>
    <description>The semiquantitative analysis will be performed by measuring the standardized uptake values (SUVs) of 18F-FDG by the IgG4-RD lesions and calculate the SUV changes before and after anti-immune treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Autoimmune Disease</condition>
  <arm_group>
    <arm_group_label>18F-FDG PET/CT scanning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>18F-FDG PET/CT scanning will be performed in patients with IgG4RD to determine the pictorial characteristics and measure the standardized uptake values (SUVs) of the lesions and their response to treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-FDG</intervention_name>
    <description>Intravenous injection of single dose of 18F-FDG before treatment and after 4-week treatment, respectively.</description>
    <arm_group_label>18F-FDG PET/CT scanning</arm_group_label>
    <other_name>18F-Fluorodeoxyglucose</other_name>
    <other_name>2-Fluoro-2-deoxy-D-glucose</other_name>
    <other_name>Fluorine-18-fluorodeoxyglucose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females&#xD;
&#xD;
          -  Age 18-75 years old with informed consent&#xD;
&#xD;
          -  Patients with IgG4-RD:&#xD;
&#xD;
               1. swelling, sclerosing and inflammatory involvement of one or more organ, including&#xD;
                  sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors,&#xD;
                  retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis,&#xD;
                  sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm,&#xD;
                  lymphadenopathy, or other inflammatory conditions;&#xD;
&#xD;
               2. elevated serum IgG4 (&gt;1.35 g/L) or with histopathologic features of fibrosis&#xD;
                  and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma&#xD;
                  cells on immunohistology when performed);&#xD;
&#xD;
               3. exclusion of other diseases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Females planning to bear a child recently or with childbearing potential;&#xD;
&#xD;
          -  Inability to complete the examination;&#xD;
&#xD;
          -  Concurrent severe and/or uncontrolled and/or unstable diseases;&#xD;
&#xD;
          -  Currently under treatment using glucocorticoids.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wen Zhang, MD</last_name>
    <role>Study Director</role>
    <affiliation>Deptment of Rheumatology, Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fang Li, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Nuclear Medicine, Peking Union Medical College Hospital, CAMS &amp; PUMC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zhaohui Zhu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Nuclear Medicine, Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hua Chen, MD</last_name>
    <phone>86-10-69158797</phone>
    <email>chen77hua@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhaohui Zhu, MD</last_name>
      <phone>86-10-69154196</phone>
      <email>zhuzhh@pumch.cn</email>
    </contact>
    <contact_backup>
      <last_name>Hua Chen, MD</last_name>
      <phone>86-10-69158797</phone>
      <email>chen77hua@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>April 5, 2017</last_update_submitted>
  <last_update_submitted_qc>April 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Zhaohui Zhu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>IgG4-related disease</keyword>
  <keyword>IgG4-RD</keyword>
  <keyword>18F-FDG</keyword>
  <keyword>PET/CT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autoimmune Diseases</mesh_term>
    <mesh_term>Immunoglobulin G4-Related Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deoxyglucose</mesh_term>
    <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>


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/NCT01665196
org study id: IgG4RD-PET
nct id: NCT01665196
lead sponsor: 
has dmc: Yes
This is an open-label study to investigate the diagnostic performance of 18F-FDG PET/CT
      (positron emission tomography/computed tomography) in evaluation of patients with
      IgG4-related disease. A single dose of 18F-FDG will be intravenously injected into patients
      with IgG4-related disease before and after treatment.
Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity
      characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and
      elevated serum IgG4 concentration. The most important feature of IgG4-RD is chronic
      inflammation with multiple organ involvement. However, some organ involvements are difficult
      to find by ultrasound, CT or MRI.

      18F-FDG PET/CT is a sensitive imaging tool for inflammation. In this study, PET/CT were
      performed in patients with IgG4-RD both before and after glucocorticoid treatment by a single
      dose of 18F-FDG. Visual and semiquantitative method will be employed to assess the PET/CT
      images. The PET/CT image data will be used to establish a diagnostic model as well as
      assessment criteria for response evaluation of IgG4-RD treatments.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Visual analysis of organ involvement and treatment response of the IgG4-RD patients.
time frame: 1 year
description: Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. The 18F-FDG PET/CT pattern of IgG4-RG will be extracted and summarized. The response to anti-immune treatment will be assessed.
measure: Semiquantitative measurement of lesion metabolism and treatment response of the IgG4-RD patients.
time frame: 1 year
description: The semiquantitative analysis will be performed by measuring the standardized uptake values (SUVs) of 18F-FDG by the IgG4-RD lesions and calculate the SUV changes before and after anti-immune treatment.
arm group label: 18F-FDG PET/CT scanning
arm group type: Experimental
description: 18F-FDG PET/CT scanning will be performed in patients with IgG4RD to determine the pictorial characteristics and measure the standardized uptake values (SUVs) of the lesions and their response to treatment.
intervention type: Drug
intervention name: 18F-FDG
description: Intravenous injection of single dose of 18F-FDG before treatment and after 4-week treatment, respectively.
arm group label: 18F-FDG PET/CT scanning
other name: 18F-Fluorodeoxyglucose
other name: 2-Fluoro-2-deoxy-D-glucose
other name: Fluorine-18-fluorodeoxyglucose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Wen Zhang, MD
role: Study Director
affiliation: Deptment of Rheumatology, Peking Union Medical College Hospital
last name: Fang Li, MD
role: Study Chair
affiliation: Department of Nuclear Medicine, Peking Union Medical College Hospital, CAMS & PUMC
last name: Zhaohui Zhu, MD
role: Principal Investigator
affiliation: Department of Nuclear Medicine, Peking Union Medical College Hospital
last name: Hua Chen, MD
phone: 86-10-69158797
email: chen77hua@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Zhaohui Zhu
investigator title: Professor
mesh term: Autoimmune Diseases
mesh term: Immunoglobulin G4-Related Disease
mesh term: Deoxyglucose
mesh term: Fluorodeoxyglucose F18
sharing ipd: No