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

NCT04467580 | Unknown

• 1 other identifier: 2020_003067-26
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

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

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Contribution of [18F]FDG PET/CT with index NET (Net Reclassification Index)

  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).

  Day 45

• Inter- and intra-observer reproducibility

  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).

  Day 45

Study Arms (1)

Patients with stenosing CD

EXPERIMENTAL

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

Interventions

abdominal [18F]FDG PET/CT DIAGNOSTIC_TEST

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).

Patients with stenosing CD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Marine CLAUDIN, MD

CONTACT

0383154276; m.claudin@chru-nancy.fr

Veronique ROCH, MSc

CONTACT

0383154276; v.roch@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 13, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: May 2, 2023
• Last Updated: July 13, 2020

Record last verified: 2020-06