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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Diagnostic test: abdominal [18F]FDG PET/CT

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: Interventional
• Enrollment (Anticipated): 59
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marine CLAUDIN, MD; Phone Number: 0383154276; Email: m.claudin@chru-nancy.fr
• Study Contact Backup: Name: VERONIQUE ROCH, MSc; Phone Number: 0383154276; Email: v.roch@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 45
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.	Day 45

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 45
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.	Day 45
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.	Day 45
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	Day 45

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): May 2, 2023

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Fibrosis; Inflammation; Crohn Disease
• Other Study ID Numbers: 2020_003067-26

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No