<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/NCT04467580</url>
  </required_header>
  <id_info>
    <org_study_id>2020_003067-26</org_study_id>
    <nct_id>NCT04467580</nct_id>
  </id_info>
  <brief_title>Development of Inflammation and Fibrosis Index, Combining MRI and PET 18F-FDG, in Patient's With Crohn's Disease</brief_title>
  <acronym>FILM</acronym>
  <official_title>Development and Validation of an Inflammation Index (FILM-i) and a Fibrosis Index (FILM-f), Combining MRI and Positron Emission Tomography (PET) With Low-dose [18F]FDG (With the Tracer Fluorine-18 (18F) Fluorodeoxyglucose (FDG), Called [18F]FDG PET Activity, to Characterize Fibrosis and Inflammation of Intestinal Strictures During Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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>
      Chronic inflammatory bowel disease (IBD) is a disabling, incurable condition that affects&#xD;
      250,000 people in France, and Crohn's disease (CD) is the most common form. CD progresses, in&#xD;
      one-quarter of the cases, towards the appearance of intestinal stenosis, most often on the&#xD;
      terminal ileum, sometimes with obstructive symptoms and requiring an optimization of medical&#xD;
      treatment (biotherapies) and/or surgery The hypothesis of this study is [18F]FDG PET /CT,&#xD;
      (Positron emission tomography with the tracer fluorine-18 (18F) fluorodeoxyglucose (FDG),&#xD;
      called [18F]FDG PET coupled to a dedicated CT scanner) could help quantify intestinal&#xD;
      inflammation in patients with abnormal entero-MRI, and differentiate inflammation and&#xD;
      fibrosis on a joint PET /CT and MRI , in patients with complicated Crohn Disease intestinal&#xD;
      stenosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intestinal inflammation could be quantified by the PET/CT due to the tropism of a PET tracer,&#xD;
      [18F]FDG for activated inflammatory cells.&#xD;
&#xD;
      [18F]FDG PET/CTperformed on latest digital PET/CT cameras and recordings focused on the&#xD;
      abdomen could help quantify intestinal inflammation in patients with abnormal entero-MRI, and&#xD;
      differentiate inflammation and fibrosis on a joint PET/CT and MRI , in patients with&#xD;
      complicated Crohn Disease intestinal stenosis.&#xD;
&#xD;
      Magnetic resonance imaging (MRI) indices are used to assess the upgradability and activity of&#xD;
      CD and try to predict response to treatment, in particular Nancy's MRI score for digestive&#xD;
      inflammation.&#xD;
&#xD;
      An inflammation index (FILM-i) and a fibrosis index (FILM-f), based on this MRI/PET analysis,&#xD;
      will be developed and validated to develop personalized medicine in patients with stenosing&#xD;
      CD. Indeed, these indices will guide the therapeutic choice, in particular for the&#xD;
      biotherapies prescription or the need to operate these patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">May 2, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</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>
    <intervention_model_description>Patient with stenosing CD and for which the surgical resection of one or more stenosis (s) of the terminal ileum is programmed as part of the treatment.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Index FILM-i</measure>
    <time_frame>Day 45</time_frame>
    <description>Index FILM-i will be developed using histological scores determined according to the extent and the diffusion in the thickness of the intestinal wall: cellular infiltration and edema&#xD;
These histological scores both include 4 grades:&#xD;
0 = no damage (fibrosis or inflammation),&#xD;
1 = slight damage,&#xD;
2 = average achievement,&#xD;
3 = severe damage. The FILM-i indice is developed in order to predict these same 4 grades.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Index FILM-f</measure>
    <time_frame>Day 45</time_frame>
    <description>Index FILM-f will be developed using histological scores determined according to the extent and the diffusion in the thickness of the intestinal wall : collagen fibrosis&#xD;
These histological scores both include 4 grades:&#xD;
0 = no damage (fibrosis or inflammation),&#xD;
1 = slight damage,&#xD;
2 = average achievement,&#xD;
3 = severe damage. The FILM-i indice is developed in order to predict these same 4 grades.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Contribution of [18F]FDG PET/CT with index NET (Net Reclassification Index)</measure>
    <time_frame>Day 45</time_frame>
    <description>Quantify the contribution of [18F]FDG PET/CT, in addition to MRI, for the characterization of the fibrotic and inflammatory components of stenosis of the terminal ileum with the index NET. This index will be calculated to quantify the contribution of PET items to the model including only MRI items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the performance of the inflammation index (FILM-i) with that of a baseline MRI score, the Nancy score, for the detection of significant colonic inflammation (moderate to severe in histopathology).</measure>
    <time_frame>Day 45</time_frame>
    <description>The performance of the FILM-i index and Nancy's score will be evaluated by the of correctly classified segments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter- and intra-observer reproducibility</measure>
    <time_frame>Day 45</time_frame>
    <description>To estimate the inter- and intra-observer reproducibility of the 4 grade classifications obtained by the FILM-i and FILM-f indices with the intra-class correlation coefficients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of correlation between FILM-i and FILM-f index and the modified histological activity score of the Global Histologic Activity Score (GHAS).</measure>
    <time_frame>Day 45</time_frame>
    <description>Compare the results of index and modified GHAS score</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">59</enrollment>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>Patients with stenosing CD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with stenosing CD will be recruited in each investigation center, during a preoperative consultation for an already decided and planned intestinal resection (digestive surgery or hepato-gastro department) -enterology).</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>abdominal [18F]FDG PET/CT</intervention_name>
    <description>Patients will have within a maximum period of 15 days before the surgery (resection of intestinal stenosis), records by MRI and by digital PET/CT with low injected activity of [18F]FDG, focused on the abdomen, the MRI will be performed maximum 30 days before the intervention (if available and performed according to the procedure for the study, it will not be repeated for the study).</description>
    <arm_group_label>Patients with stenosing CD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major subject having received complete information of the clinical research and having&#xD;
             signed their informed consent&#xD;
&#xD;
          -  Subject with a stenosing CD (objectified on MRI, CT and / or endoscopy).&#xD;
&#xD;
          -  Subject for which surgical resection of one or more stenosis (s) of the terminal ileum&#xD;
             is programmed as part of the treatment.&#xD;
&#xD;
          -  Subject with a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject having a contraindication to performing MRI and / or PET / CT at 18F-FDG.&#xD;
&#xD;
          -  Subject with an ostomy&#xD;
&#xD;
          -  Diabetic subject treated by metformin.&#xD;
&#xD;
          -  Subject referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health&#xD;
             code.&#xD;
&#xD;
          -  Pregnant woman, parturient or nursing mother.&#xD;
&#xD;
          -  Subject with a legal protection measure (guardianship, curatorship, safeguard of&#xD;
             justice).&#xD;
&#xD;
          -  Subject unable to express consent.&#xD;
&#xD;
          -  Subject deprived of their liberty by a judicial or administrative decision, persons&#xD;
             subject to psychiatric care under articles L. 3212-1 and L.3213-1.&#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>Marine CLAUDIN, MD</last_name>
    <phone>0383154276</phone>
    <email>m.claudin@chru-nancy.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Veronique ROCH, MSc</last_name>
    <phone>0383154276</phone>
    <email>v.roch@chru-nancy.fr</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 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>
    <mesh_term>Fibrosis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- 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/NCT04467580
org study id: 2020_003067-26
nct id: NCT04467580
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic inflammatory bowel disease (IBD) is a disabling, incurable condition that affects
      250,000 people in France, and Crohn's disease (CD) is the most common form. CD progresses, in
      one-quarter of the cases, towards the appearance of intestinal stenosis, most often on the
      terminal ileum, sometimes with obstructive symptoms and requiring an optimization of medical
      treatment (biotherapies) and/or surgery The hypothesis of this study is [18F]FDG PET /CT,
      (Positron emission tomography with the tracer fluorine-18 (18F) fluorodeoxyglucose (FDG),
      called [18F]FDG PET coupled to a dedicated CT scanner) could help quantify intestinal
      inflammation in patients with abnormal entero-MRI, and differentiate inflammation and
      fibrosis on a joint PET /CT and MRI , in patients with complicated Crohn Disease intestinal
      stenosis
Intestinal inflammation could be quantified by the PET/CT due to the tropism of a PET tracer,
      [18F]FDG for activated inflammatory cells.

      [18F]FDG PET/CTperformed on latest digital PET/CT cameras and recordings focused on the
      abdomen could help quantify intestinal inflammation in patients with abnormal entero-MRI, and
      differentiate inflammation and fibrosis on a joint PET/CT and MRI , in patients with
      complicated Crohn Disease intestinal stenosis.

      Magnetic resonance imaging (MRI) indices are used to assess the upgradability and activity of
      CD and try to predict response to treatment, in particular Nancy's MRI score for digestive
      inflammation.

      An inflammation index (FILM-i) and a fibrosis index (FILM-f), based on this MRI/PET analysis,
      will be developed and validated to develop personalized medicine in patients with stenosing
      CD. Indeed, these indices will guide the therapeutic choice, in particular for the
      biotherapies prescription or the need to operate these patients.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patient with stenosing CD and for which the surgical resection of one or more stenosis (s) of the terminal ileum is programmed as part of the treatment.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Index FILM-i
time frame: Day 45
description: Index FILM-i will be developed using histological scores determined according to the extent and the diffusion in the thickness of the intestinal wall: cellular infiltration and edema
These histological scores both include 4 grades:
0 = no damage (fibrosis or inflammation),
1 = slight damage,
2 = average achievement,
3 = severe damage. The FILM-i indice is developed in order to predict these same 4 grades.
measure: Index FILM-f
time frame: Day 45
description: Index FILM-f will be developed using histological scores determined according to the extent and the diffusion in the thickness of the intestinal wall : collagen fibrosis
These histological scores both include 4 grades:
0 = no damage (fibrosis or inflammation),
1 = slight damage,
2 = average achievement,
3 = severe damage. The FILM-i indice is developed in order to predict these same 4 grades.
measure: Contribution of [18F]FDG PET/CT with index NET (Net Reclassification Index)
time frame: Day 45
description: Quantify the contribution of [18F]FDG PET/CT, in addition to MRI, for the characterization of the fibrotic and inflammatory components of stenosis of the terminal ileum with the index NET. This index will be calculated to quantify the contribution of PET items to the model including only MRI items.
measure: To compare the performance of the inflammation index (FILM-i) with that of a baseline MRI score, the Nancy score, for the detection of significant colonic inflammation (moderate to severe in histopathology).
time frame: Day 45
description: The performance of the FILM-i index and Nancy's score will be evaluated by the of correctly classified segments.
measure: Inter- and intra-observer reproducibility
time frame: Day 45
description: To estimate the inter- and intra-observer reproducibility of the 4 grade classifications obtained by the FILM-i and FILM-f indices with the intra-class correlation coefficients.
measure: Degree of correlation between FILM-i and FILM-f index and the modified histological activity score of the Global Histologic Activity Score (GHAS).
time frame: Day 45
description: Compare the results of index and modified GHAS score
arm group label: Patients with stenosing CD
arm group type: Experimental
description: Patients with stenosing CD will be recruited in each investigation center, during a preoperative consultation for an already decided and planned intestinal resection (digestive surgery or hepato-gastro department) -enterology).
intervention type: Diagnostic Test
intervention name: abdominal [18F]FDG PET/CT
description: Patients will have within a maximum period of 15 days before the surgery (resection of intestinal stenosis), records by MRI and by digital PET/CT with low injected activity of [18F]FDG, focused on the abdomen, the MRI will be performed maximum 30 days before the intervention (if available and performed according to the procedure for the study, it will not be repeated for the study).
arm group label: Patients with stenosing CD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marine CLAUDIN, MD
phone: 0383154276
email: m.claudin@chru-nancy.fr
last name: Veronique ROCH, MSc
phone: 0383154276
email: v.roch@chru-nancy.fr
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Fibrosis
mesh term: Inflammation