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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

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

Condition or disease Intervention/treatment Phase
Crohn Disease Diagnostic Test: abdominal [18F]FDG PET/CT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
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
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
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : May 2, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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).
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).




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04467580


Contacts
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Contact: Marine CLAUDIN, MD 0383154276 m.claudin@chru-nancy.fr
Contact: Veronique ROCH, MSc 0383154276 v.roch@chru-nancy.fr

Sponsors and Collaborators
Central Hospital, Nancy, France
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04467580    
Other Study ID Numbers: 2020_003067-26
First Posted: July 13, 2020    Key Record Dates
Last Update Posted: July 13, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Fibrosis
Inflammation
Pathologic Processes
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases