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

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ClinicalTrials.gov Identifier: NCT04467580
Recruitment Status : Not yet recruiting
First Posted : July 13, 2020
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Tracking Information
First Submitted Date  ICMJE June 22, 2020
First Posted Date  ICMJE July 13, 2020
Last Update Posted Date July 13, 2020
Estimated Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2020)
  • Index FILM-i [ Time Frame: Day 45 ]
    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 [ Time Frame: Day 45 ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2020)
  • Contribution of [18F]FDG PET/CT with index NET (Net Reclassification Index) [ Time Frame: Day 45 ]
    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). [ Time Frame: Day 45 ]
    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 [ Time Frame: Day 45 ]
    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). [ Time Frame: Day 45 ]
    Compare the results of index and modified GHAS score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of Inflammation and Fibrosis Index, Combining MRI and PET 18F-FDG, in Patient's With Crohn's Disease
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Crohn Disease
Intervention  ICMJE Diagnostic Test: abdominal [18F]FDG PET/CT
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).
Study Arms  ICMJE Experimental: Patients with stenosing CD
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: Diagnostic Test: abdominal [18F]FDG PET/CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2020)
59
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2, 2023
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marine CLAUDIN, MD 0383154276 m.claudin@chru-nancy.fr
Contact: Veronique ROCH, MSc 0383154276 v.roch@chru-nancy.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04467580
Other Study ID Numbers  ICMJE 2020_003067-26
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Central Hospital, Nancy, France
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Central Hospital, Nancy, France
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Central Hospital, Nancy, France
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP