Assessment of Fibrotic and Inflammatory Components by MRI in Strictures Associated With Eosinophilic Esophagitis Before and After Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Measurement of distinct inflammatory and fibrotic components of the esophageal stricture in patients with eosinophilic esophagitis
研究概览
简要总结
Can an MRI detect and monitor the inflammatory and fibrotic possess in patients with Eosinophilic Esophagitis
详细描述
MRI will be performed on a 1.5T magnet. Patients will be scanned in an oblique prone position similar to how esophageal distention is assessed at barium fluoroscopy. The following sequences and rationale will be used for the examination:
A sagittal 50mm thick multiphase FIESTA and multiphase SSFSE will be performed while the patient drinks water. The temporal resolution of the images will be approximately 1 image every 1.5-2 seconds. The images will be used to assess the lumen caliber and the wall thickness during maximal distension as pseudothickening can occur with decreased luminal distension.
Sagittal SSFSE with fat suppression, sagittal FRFSE T2-weighted images with fat suppression, axial DWI and sagittal DWI will be performed to asses for edema and inflammation within the esophageal wall.
axial FS SSFSE or FIESTA will be performed and targeted to the region of stricturing.
Dynamic sagittal imaging will be performed following IV contrast to assess for mural hyperenhancement which can be seen mural inflammation and delayed enhancement which can be seen in fibrosis. Sequential acquisitions will be performed beginning at 40 seconds following IV contrast injection. Delayed acquisitions will be performed at 5 min and 7 min. Patients will be asked to perform swallowing during the image acquisition to reduce the potential for pseudoenhancement secondary to under distension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 18-70 years of age
- •Diagnosis of EoE, i.e. symptoms of esophageal dysfunction with histologic finding of 15 or more eosinophils per high power field on esophageal biopsy despite 8 weeks of high dose proton pump inhibitor therapy.
- •All Subjects diagnosed with Eosinophilic Esophagitis pre and pose therapy
排除标准
- •Clinical evidence of infectious process potentially contributing to dysphagia (e.g. candidiasis, CMV, herpes)
- •Other cause of dysphagia identified at endoscopy or esophagram (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm)
- •Esophageal minimal diameter < 13 mm on structured barium esophagram
- •Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
- •Pregnant women
- •Presence of body metallic fragments or devices that prohibit use of MRI
- •History of renal disease
- •eGRF <30
研究组 & 干预措施
MRI to detect inflammation and fibrosis in EoE patients
To assess through MRI the existence of an inflammatory and fibrotic component in strictures of eosinophilic esophagitis patients and to determine if this component is responsive to a therapeutic course of budesonide.
干预措施: MRI to detect inflammation and fibrosis in subjects with EoE (Diagnostic Test)
结局指标
主要结局
Measurement of distinct inflammatory and fibrotic components of the esophageal stricture in patients with eosinophilic esophagitis
时间窗: 1 day
At 5,15 and 25 cm above the gastroesophageal junction and in areas of obvious esophageal thickness, digitized areas of inflammation and fibrosis will be measured individually and as a proportion of overall esophageal diameter in that area before and after steroid treatment.
次要结局
- Barium Esophagram(1 day)
- Eosinophilic Esophagitis Activity Index (EEsAI)(1 day)