<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/NCT04502303</url>
  </required_header>
  <id_info>
    <org_study_id>FAPICD</org_study_id>
    <nct_id>NCT04502303</nct_id>
  </id_info>
  <brief_title>18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease</brief_title>
  <official_title>A Prospective Study to Evaluate the Inflammation and Fibrosis of Intestinal Stricture in Patients With Crohn's Disease by 18F-FDG and 68Ga-FAPI PET/CT</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>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>
      Intestinal stricture is a complication of Crohn's disease (CD), which is thought to be the&#xD;
      result of chronic transmural inflammation combined with a dysregulated wound-healing process.&#xD;
      While inflammatory strictures may respond to anti-inflammatory treatment, fibrotic strictures&#xD;
      are usually anti-inflammation resistant, requiring further endoscopic balloon dilation or&#xD;
      surgical intervention. Therefore, to determinate the inflammatory or fibrotic nature of&#xD;
      intestinal stricture is a key step in the treatment of CD. 18F-FDG is a radiotracer&#xD;
      reflecting the glucose metabolism of disease and is usually accumulated in inflammatory&#xD;
      disease. 68Ga-FAPI is a novel radiotracer that specifically targets fibroblast activation&#xD;
      protein (FAP). FAP is a membrane glycoprotein expressed on activated fibroblasts, which are&#xD;
      key cells in the process of fibrotic intestinal stricture of CD. In this study, we hypothesis&#xD;
      that the inflammatory or fibrotic nature of intestinal stricture can be non-invasively&#xD;
      evaluated by 18F-FDG and 68Ga-FAPI PET/CT in patients with CD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with intestinal stricture will undergo 18F-FDG and 68Ga-FAPI PET/CT on two&#xD;
      consectutive days. The accumulation of 18F-FDG and 68Ga-FAPI at the site of stricture will be&#xD;
      determined by standard uptake value (SUV), molecular volume (MV), and total molecular index&#xD;
      (TMI). In patients with a planned surgical resection of one or more stricture (s), the image&#xD;
      results will be compared with histological findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Patients with intestinal stricture will undergo 18F-FDG and 68Ga-FAPI PET/CT on two consecutive days.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SUVmax of stenotic intestine</measure>
    <time_frame>Day 30 after PET scan</time_frame>
    <description>The SUVmax of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the highest extent of inflammation and fibrosis, respectively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MV of stenotic intestine</measure>
    <time_frame>Day 30 after PET scan</time_frame>
    <description>The MV of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the involved area of inflammation and fibrosis, respectively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TMI of stenotic intestine</measure>
    <time_frame>Day 30 after PET scan</time_frame>
    <description>The TMI of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the overall extent of inflammation and fibrosis, respectively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Histological findings</measure>
    <time_frame>Day 90 after surgery</time_frame>
    <description>In patients with surgical resection of stenotic intestine, the extent of inflammation and fibrosis will be determined.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>Crohn's disease: patients with intestinal stricture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with intestinal strictures confirmed by other modalities, e.g. CT, MR, ultrasound, and endoscopy, will be recruited in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>18F-FDG and 68Ga-FAPI PET/CT</intervention_name>
    <description>Participants will undergo 18F-FDG (0.12-0.15mCi/kg) and 68Ga-FAPI (3-6mCi) PET/CT on two consecutive days. At least 6 hours of fast is required for 18F-FDG PET scan, while no dietary control is necessary for 68Ga-FAPI PET scan. If the patients are on metformin, discontinuation of 48 hours is required before 18F-FDG injection to minimize the bowel uptake. If the patient is planned for surgical resection of one or more stricture (s), the scans have to be completed within a maximum period of 30 days before the surgery.</description>
    <arm_group_label>Crohn's disease: patients with intestinal stricture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent signed&#xD;
&#xD;
          -  Crohn's disease patients with proofs of intestine stricture by other modalities, e.g.&#xD;
             MRI, CT, ultrasound, and/or endoscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to any of the excipients of 18F-FDG and 68Ga-FAPI.&#xD;
&#xD;
          -  If the patients are on metformin, discontinuation of 48 hours is required before&#xD;
             18F-FDG injection to minimize the bowel uptake.&#xD;
&#xD;
          -  Pregnant or breast-feeding women.&#xD;
&#xD;
          -  Any mental condition rendering the patient unable to understand the nature, scope, and&#xD;
             possible consequences of the study, and/or evidence of an uncooperative attitude.&#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_contact>
    <last_name>Wenjia Zhu, MD</last_name>
    <phone>+86 18614080164</phone>
    <email>zhuwenjia_pumc@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Li Huo, MD</last_name>
    <phone>+86 13910801986</phone>
    <email>zhuwenjia_pumc@163.com</email>
  </overall_contact_backup>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</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>Crohn Disease</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>Undecided</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/NCT04502303
org study id: FAPICD
nct id: NCT04502303
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Intestinal stricture is a complication of Crohn's disease (CD), which is thought to be the
      result of chronic transmural inflammation combined with a dysregulated wound-healing process.
      While inflammatory strictures may respond to anti-inflammatory treatment, fibrotic strictures
      are usually anti-inflammation resistant, requiring further endoscopic balloon dilation or
      surgical intervention. Therefore, to determinate the inflammatory or fibrotic nature of
      intestinal stricture is a key step in the treatment of CD. 18F-FDG is a radiotracer
      reflecting the glucose metabolism of disease and is usually accumulated in inflammatory
      disease. 68Ga-FAPI is a novel radiotracer that specifically targets fibroblast activation
      protein (FAP). FAP is a membrane glycoprotein expressed on activated fibroblasts, which are
      key cells in the process of fibrotic intestinal stricture of CD. In this study, we hypothesis
      that the inflammatory or fibrotic nature of intestinal stricture can be non-invasively
      evaluated by 18F-FDG and 68Ga-FAPI PET/CT in patients with CD.
Patients with intestinal stricture will undergo 18F-FDG and 68Ga-FAPI PET/CT on two
      consectutive days. The accumulation of 18F-FDG and 68Ga-FAPI at the site of stricture will be
      determined by standard uptake value (SUV), molecular volume (MV), and total molecular index
      (TMI). In patients with a planned surgical resection of one or more stricture (s), the image
      results will be compared with histological findings.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients with intestinal stricture will undergo 18F-FDG and 68Ga-FAPI PET/CT on two consecutive days.
primary purpose: Diagnostic
masking: None (Open Label)
measure: SUVmax of stenotic intestine
time frame: Day 30 after PET scan
description: The SUVmax of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the highest extent of inflammation and fibrosis, respectively.
measure: MV of stenotic intestine
time frame: Day 30 after PET scan
description: The MV of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the involved area of inflammation and fibrosis, respectively.
measure: TMI of stenotic intestine
time frame: Day 30 after PET scan
description: The TMI of stenotic intestine will be determined on 18F-FDG and 68Ga-FAPI PET scan to reflect the overall extent of inflammation and fibrosis, respectively.
measure: Histological findings
time frame: Day 90 after surgery
description: In patients with surgical resection of stenotic intestine, the extent of inflammation and fibrosis will be determined.
arm group label: Crohn's disease: patients with intestinal stricture
arm group type: Experimental
description: Patients with intestinal strictures confirmed by other modalities, e.g. CT, MR, ultrasound, and endoscopy, will be recruited in the study.
intervention type: Diagnostic Test
intervention name: 18F-FDG and 68Ga-FAPI PET/CT
description: Participants will undergo 18F-FDG (0.12-0.15mCi/kg) and 68Ga-FAPI (3-6mCi) PET/CT on two consecutive days. At least 6 hours of fast is required for 18F-FDG PET scan, while no dietary control is necessary for 68Ga-FAPI PET scan. If the patients are on metformin, discontinuation of 48 hours is required before 18F-FDG injection to minimize the bowel uptake. If the patient is planned for surgical resection of one or more stricture (s), the scans have to be completed within a maximum period of 30 days before the surgery.
arm group label: Crohn's disease: patients with intestinal stricture
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wenjia Zhu, MD
phone: +86 18614080164
email: zhuwenjia_pumc@163.com
last name: Li Huo, MD
phone: +86 13910801986
email: zhuwenjia_pumc@163.com
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Fluorodeoxyglucose F18
sharing ipd: Undecided