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/NCT05999643</url>
    </required_header>
    <id_info>
      <org_study_id>FAPI in SpA</org_study_id>
      <nct_id>NCT05999643</nct_id>
    </id_info>
    <brief_title>Characterizing Spondyloarthritis With 68Ga-FAPI PET/CT</brief_title>
    <official_title>Characterizing Spondyloarthritis With 68Ga-FAPI PET/CT</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital of Xiamen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital of Xiamen University</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>
        To evaluate the potential usefulness of 68Ga-FAPI PET/CT for the diagnosis, inflammation&#xD;
        evaluation and prognosis prediction in spondyloarthritis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Spondyloarthritis (SpA) is a chronic inflammatory rheumatic disease characterized by&#xD;
        inflammatory back pain, enthesitis, dactylitis, and the formation of syndesmophytes, all of&#xD;
        which significantly affect a patient's healthy functioning and general quality of life.&#xD;
        Prevalence of underlying malignancy is high in patients with SpA. Radiographic sacroiliitis&#xD;
        became a crucial finding in the diagnosis and classification of patients.&#xD;
  &#xD;
        68Ga-FAPI has been developed as tracers specific for fibroblast-activation protein (FAP),&#xD;
        which is overexpressed in activated fibroblasts in various type of cancers and autoimmune&#xD;
        diseases, such as rheumatoid arthritis, IgG4-related diseases and interstitial lung diseases.&#xD;
  &#xD;
        Recently the investigators have published articles of the application of 68Ga-FAPI in&#xD;
        IgG4-related disease and rheumatoid arthritis, which showed it was more sensitive than FDG in&#xD;
        detecting a certain type of inflammation. Increased 68Ga-FAPI Uptake in ankylosing&#xD;
        spondylitis in a patient with rectal cancer has also been reported in a case report,&#xD;
        indicating the potential utility of FAP-targeted PET/CT imaging for diagnosis and disease&#xD;
        assessment in spondyloarthritis.&#xD;
  &#xD;
        Thus, this prospective study is going to investigate utility of 68Ga-FAPI PET/CT in diagnosis&#xD;
        of spondyloarthritis as well as inflammation assessment in joints including the sacroiliac&#xD;
        (SI) joints, spine and peripheral joints. Also, this study aims to investigate potential&#xD;
        utility of 68Ga-FAPI PET/CT in predicting treatment response and disease prognosis such as&#xD;
        formation of syndesmophytes and erosive changes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>To define the distribution pattern of 68Ga-FAPI in SpA patients.</measure>
      <time_frame>60 minutes following injection</time_frame>
      <description>To quantify 68Ga-FAPI tracer biodistribution in characteristic inflammatory tissue including SI joints, spine, and the peripheral joints versus conventional x ray examination or magnetic resonance imaging (MRI) techniques in adult active SpA. 68Ga-FAPI PET tracer biodistribution will be assessed by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation between uptake of 68GA-FAPI and other parameters associated with disease activity.</measure>
      <time_frame>30 days</time_frame>
      <description>Correlation between uptake of 68GA-FAPI and parameters associated with disease activity including Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath ankylosing spondylitis disease activity index (BSADAI）, Bath ankylosing spondylitis functional index (BASFI)，and Maastricht Ankylosing Spondylitis Enthesitis Score（MASES). The Standardized uptake value (SUV) of 68Ga-FAPI was calculated and analyzing the correlation between pathological results and parameters associated with disease activity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between uptake of 68GA-FAPI change and disease activity change</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Correlation between change in standardized uptake value (SUV) of 68Ga-FAPI at inflammatory site with change in Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath ankylosing spondylitis disease activity index (BSADAI), Bath ankylosing spondylitis functional index (BASFI)，and Maastricht Ankylosing Spondylitis Enthesitis Score（MASES) at different disease stage.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between uptake of 68GA-FAPI and therapy response</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Percentage of participants achieving ankylosing spondylitis disease activity score inactive disease [ASDAS ID (&lt;1.3)] after 1 year standardized treatment in participants with high standardized uptake value (SUV) of 68Ga-FAPI and low standardized uptake value (SUV) of 68Ga-FAPI at baseline.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Spondyloarthritis</condition>
    <condition>Axial Spondyloarthritis</condition>
    <condition>Ankylosing Spondylitis</condition>
    <arm_group>
      <arm_group_label>Inject 68Ga-FAPI and then perform PET/CT scan.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Inject 68Ga-FAPI and then perform PET/CT scan</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Drug: 68Ga-FAPI</intervention_name>
      <description>Intravenous injection of one dosage of 111-185 MBq (3-5 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image SpA lesions in SI joints, spine, musculoskeletal and the extra-articular involvement by PET/CT.</description>
      <arm_group_label>Inject 68Ga-FAPI and then perform PET/CT scan.</arm_group_label>
      <other_name>68Ga-fibroblast activating protein inhibitors</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. A diagnosis of SpA according to the ASAS (Assessment of Spondyloarthritis&#xD;
               International Society) classification criteria for SpA.&#xD;
  &#xD;
            2. Adult men or women 18 and ≤ 65 years of age at the time of signing the informed&#xD;
               consent (ICF).&#xD;
  &#xD;
            3. participants who were able to provide informed consent (signed by participant or legal&#xD;
               representative) and assent according to the guidelines of the Clinical Research Ethics&#xD;
               Committee.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnancy;&#xD;
  &#xD;
            2. Breastfeeding;&#xD;
  &#xD;
            3. known allergy against FAPI;&#xD;
  &#xD;
            4. any medical condition that in the opinion of the investigator may significantly&#xD;
               interfere with study compliance.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guixiu Shi, PhD</last_name>
      <role>Study Director</role>
      <affiliation>The First Affiliated Hospital of Xiamen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yuan Liu, MD</last_name>
      <phone>86 0592-2137749</phone>
      <email>iuyuan@xmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Haojun Chen, PhD</last_name>
      <phone>86 0592-2137166</phone>
      <email>leochen0821@foxmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The first affiliated hospital of Xiamen University</name>
        <address>
          <city>Xiamen</city>
          <state>Fujian</state>
          <zip>361000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qiuwan Wu, PhD</last_name>
        <phone>86 0592-2137507</phone>
      </contact>
      <investigator>
        <last_name>Yuan Liu, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Haojun Chen, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 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>
    <keyword>Spondyloarthritis</keyword>
    <keyword>Axial Spondyloarthritis</keyword>
    <keyword>Ankylosing Spondylitis</keyword>
    <keyword>68Ga-FAPI</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spondylitis</mesh_term>
      <mesh_term>Spondylarthritis</mesh_term>
      <mesh_term>Spondylitis, Ankylosing</mesh_term>
      <mesh_term>Axial Spondyloarthritis</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/NCT05999643
  org study id: FAPI in SpA
  nct id: NCT05999643
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the potential usefulness of 68Ga-FAPI PET/CT for the diagnosis, inflammation
        evaluation and prognosis prediction in spondyloarthritis.
  Spondyloarthritis (SpA) is a chronic inflammatory rheumatic disease characterized by
        inflammatory back pain, enthesitis, dactylitis, and the formation of syndesmophytes, all of
        which significantly affect a patient's healthy functioning and general quality of life.
        Prevalence of underlying malignancy is high in patients with SpA. Radiographic sacroiliitis
        became a crucial finding in the diagnosis and classification of patients.
  
        68Ga-FAPI has been developed as tracers specific for fibroblast-activation protein (FAP),
        which is overexpressed in activated fibroblasts in various type of cancers and autoimmune
        diseases, such as rheumatoid arthritis, IgG4-related diseases and interstitial lung diseases.
  
        Recently the investigators have published articles of the application of 68Ga-FAPI in
        IgG4-related disease and rheumatoid arthritis, which showed it was more sensitive than FDG in
        detecting a certain type of inflammation. Increased 68Ga-FAPI Uptake in ankylosing
        spondylitis in a patient with rectal cancer has also been reported in a case report,
        indicating the potential utility of FAP-targeted PET/CT imaging for diagnosis and disease
        assessment in spondyloarthritis.
  
        Thus, this prospective study is going to investigate utility of 68Ga-FAPI PET/CT in diagnosis
        of spondyloarthritis as well as inflammation assessment in joints including the sacroiliac
        (SI) joints, spine and peripheral joints. Also, this study aims to investigate potential
        utility of 68Ga-FAPI PET/CT in predicting treatment response and disease prognosis such as
        formation of syndesmophytes and erosive changes.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: To define the distribution pattern of 68Ga-FAPI in SpA patients.
  time frame: 60 minutes following injection
  description: To quantify 68Ga-FAPI tracer biodistribution in characteristic inflammatory tissue including SI joints, spine, and the peripheral joints versus conventional x ray examination or magnetic resonance imaging (MRI) techniques in adult active SpA. 68Ga-FAPI PET tracer biodistribution will be assessed by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)).
  measure: Correlation between uptake of 68GA-FAPI and other parameters associated with disease activity.
  time frame: 30 days
  description: Correlation between uptake of 68GA-FAPI and parameters associated with disease activity including Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath ankylosing spondylitis disease activity index (BSADAI）, Bath ankylosing spondylitis functional index (BASFI)，and Maastricht Ankylosing Spondylitis Enthesitis Score（MASES). The Standardized uptake value (SUV) of 68Ga-FAPI was calculated and analyzing the correlation between pathological results and parameters associated with disease activity.
  measure: Correlation between uptake of 68GA-FAPI change and disease activity change
  time frame: Up to 2 years
  description: Correlation between change in standardized uptake value (SUV) of 68Ga-FAPI at inflammatory site with change in Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath ankylosing spondylitis disease activity index (BSADAI), Bath ankylosing spondylitis functional index (BASFI)，and Maastricht Ankylosing Spondylitis Enthesitis Score（MASES) at different disease stage.
  measure: Correlation between uptake of 68GA-FAPI and therapy response
  time frame: Up to 2 years
  description: Percentage of participants achieving ankylosing spondylitis disease activity score inactive disease [ASDAS ID (<1.3)] after 1 year standardized treatment in participants with high standardized uptake value (SUV) of 68Ga-FAPI and low standardized uptake value (SUV) of 68Ga-FAPI at baseline.
  arm group label: Inject 68Ga-FAPI and then perform PET/CT scan.
  arm group type: Experimental
  description: Inject 68Ga-FAPI and then perform PET/CT scan
  intervention type: Diagnostic Test
  intervention name: Drug: 68Ga-FAPI
  description: Intravenous injection of one dosage of 111-185 MBq (3-5 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image SpA lesions in SI joints, spine, musculoskeletal and the extra-articular involvement by PET/CT.
  arm group label: Inject 68Ga-FAPI and then perform PET/CT scan.
  other name: 68Ga-fibroblast activating protein inhibitors
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Guixiu Shi, PhD
  role: Study Director
  affiliation: The First Affiliated Hospital of Xiamen University
  last name: Yuan Liu, MD
  phone: 86 0592-2137749
  email: iuyuan@xmu.edu.cn
  last name: Haojun Chen, PhD
  phone: 86 0592-2137166
  email: leochen0821@foxmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Spondylitis
  mesh term: Spondylarthritis
  mesh term: Spondylitis, Ankylosing
  mesh term: Axial Spondyloarthritis
  sharing ipd: No