MRI to Assess Fibrosis in Eosinophilic Esophagitis Patients

Not Applicable

Terminated

• Conditions: Eosinophilic Esophagitis
• Interventions: Diagnostic Test: MRI to detect inflammation and fibrosis in subjects with EoE

• Registration Number: NCT03446118
• Lead Sponsor: Mayo Clinic

Brief Summary

Can an MRI detect and monitor the inflammatory and fibrotic possess in patients with Eosinophilic Esophagitis

Detailed Description

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.

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-12-27
• Study First Submitted QC: 2018-02-19
• Study First Posted: 2018-02-26
• Primary Completion: 2019-04-15
• Study Completion: 2019-04-15
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI to detect inflammation and fibrosis in EoE patients	MRI to detect inflammation and fibrosis in subjects with EoE	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.

Primary Outcome Measures

Name	Time	Method
Measurement of distinct inflammatory and fibrotic components of the esophageal stricture in patients with eosinophilic esophagitis	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.

Secondary Outcome Measures

Name	Time	Method
Barium Esophagram	1 day	The barium esophagram will measure moderate stricture formation to delineate the groups- Group 1.(narrowed segment \<8 cm in length and lumen diameter \> 12mm) and Group 2- 10 will have small caliber esophagus (a narrowed segment \>8 cm in length with minimum diameter \< 10mm).
Eosinophilic Esophagitis Activity Index (EEsAI)	1 day	Questionnaire developed to measure dysphagia - using the pro scoring method

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States