Clinical trial NCT04467580: Development of Inflammation and Fibrosis Index, Combining MRI and PET 18F-FDG, in Patient's With Crohn's Disease
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
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

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.

Primary outcomes:
measure: Index FILM-i
timeFrame: Day 45
measure: Index FILM-f
timeFrame: Day 45
Secondary outcomes:
measure: Contribution of [18F]FDG PET/CT with index NET (Net Reclassification Index)
timeFrame: Day 45
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).
timeFrame: Day 45
measure: Inter- and intra-observer reproducibility
timeFrame: Day 45
measure: Degree of correlation between FILM-i and FILM-f index and the modified histological activity score of the Global Histologic Activity Score (GHAS).
timeFrame: Day 45
Other outcomes:
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