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Development of Inflammation and Fibrosis Index, Combining MRI and PET 18F-FDG, in Patient's With Crohn's Disease (FILM)

Primary Purpose

Crohn Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
abdominal [18F]FDG PET/CT
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Major subject having received complete information of the clinical research and having signed their informed consent
  • Subject with a stenosing CD (objectified on MRI, CT and / or endoscopy).
  • Subject for which surgical resection of one or more stenosis (s) of the terminal ileum is programmed as part of the treatment.
  • Subject with a social security scheme

Exclusion Criteria:

  • Subject having a contraindication to performing MRI and / or PET / CT at 18F-FDG.
  • Subject with an ostomy
  • Diabetic subject treated by metformin.
  • Subject referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code.
  • Pregnant woman, parturient or nursing mother.
  • Subject with a legal protection measure (guardianship, curatorship, safeguard of justice).
  • Subject unable to express consent.
  • Subject deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L.3213-1.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patients with stenosing CD

    Arm 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).

    Outcomes

    Primary Outcome Measures

    Index FILM-i
    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.
    Index FILM-f
    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.

    Secondary Outcome Measures

    Contribution of [18F]FDG PET/CT with index NET (Net Reclassification Index)
    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.
    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).
    The performance of the FILM-i index and Nancy's score will be evaluated by the of correctly classified segments.
    Inter- and intra-observer reproducibility
    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.
    Degree of correlation between FILM-i and FILM-f index and the modified histological activity score of the Global Histologic Activity Score (GHAS).
    Compare the results of index and modified GHAS score

    Full Information

    First Posted
    June 22, 2020
    Last Updated
    July 8, 2020
    Sponsor
    Central Hospital, Nancy, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04467580
    Brief Title
    Development of Inflammation and Fibrosis Index, Combining MRI and PET 18F-FDG, in Patient's With Crohn's Disease
    Acronym
    FILM
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    September 1, 2022 (Anticipated)
    Study Completion Date
    May 2, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Central Hospital, Nancy, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Crohn Disease

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    59 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with stenosing CD
    Arm Type
    Experimental
    Arm 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(s)
    abdominal [18F]FDG PET/CT
    Intervention 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).
    Primary Outcome Measure Information:
    Title
    Index FILM-i
    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.
    Time Frame
    Day 45
    Title
    Index FILM-f
    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.
    Time Frame
    Day 45
    Secondary Outcome Measure Information:
    Title
    Contribution of [18F]FDG PET/CT with index NET (Net Reclassification Index)
    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.
    Time Frame
    Day 45
    Title
    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).
    Description
    The performance of the FILM-i index and Nancy's score will be evaluated by the of correctly classified segments.
    Time Frame
    Day 45
    Title
    Inter- and intra-observer reproducibility
    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.
    Time Frame
    Day 45
    Title
    Degree of correlation between FILM-i and FILM-f index and the modified histological activity score of the Global Histologic Activity Score (GHAS).
    Description
    Compare the results of index and modified GHAS score
    Time Frame
    Day 45

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Major subject having received complete information of the clinical research and having signed their informed consent Subject with a stenosing CD (objectified on MRI, CT and / or endoscopy). Subject for which surgical resection of one or more stenosis (s) of the terminal ileum is programmed as part of the treatment. Subject with a social security scheme Exclusion Criteria: Subject having a contraindication to performing MRI and / or PET / CT at 18F-FDG. Subject with an ostomy Diabetic subject treated by metformin. Subject referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code. Pregnant woman, parturient or nursing mother. Subject with a legal protection measure (guardianship, curatorship, safeguard of justice). Subject unable to express consent. Subject deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L.3213-1.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marine CLAUDIN, MD
    Phone
    0383154276
    Email
    m.claudin@chru-nancy.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Veronique ROCH, MSc
    Phone
    0383154276
    Email
    v.roch@chru-nancy.fr

    12. IPD Sharing Statement

    Learn more about this trial

    Development of Inflammation and Fibrosis Index, Combining MRI and PET 18F-FDG, in Patient's With Crohn's Disease

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