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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 59
- 主要终点
- Index FILM-i
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Index FILM-i
时间窗: 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.
Index FILM-f
时间窗: 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.
次要结局
- Inter- and intra-observer reproducibility(Day 45)
- 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)
- 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)