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

Central Hospital, Nancy, France

Status: Unknown

Conditions: Crohn Disease

Treatments: Diagnostic Test: abdominal [18F]FDG PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT04467580

2020_003067-26

Details and patient eligibility

About

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

Full 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.

Enrollment: 59 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Patients with stenosing CD

Experimental group

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).

Treatment:

Diagnostic Test: abdominal [18F]FDG PET/CT