MRI to Assess Fibrosis in Eosinophilic Esophagitis Patients (EoE)

Assessment of Fibrotic and Inflammatory Components by MRI in Strictures Associated With Eosinophilic Esophagitis Before and After Treatment

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

Study Overview

• Status: Terminated
• Conditions: Eosinophilic Esophagitis
• Intervention / Treatment: Diagnostic test: MRI to detect inflammation and fibrosis in subjects with EoE

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Diagnostic test: MRI to detect inflammation and fibrosis in subjects with EoE; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of distinct inflammatory and fibrotic components of the esophageal stricture in patients with eosinophilic esophagitis	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barium Esophagram	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).	1 day
Eosinophilic Esophagitis Activity Index (EEsAI)	Questionnaire developed to measure dysphagia - using the pro scoring method	1 day

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): April 15, 2019
• Study Completion (ACTUAL): April 15, 2019

Study Registration Dates

• First Submitted: December 27, 2017
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (ACTUAL): February 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: EoE
• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Hypersensitivity; Esophageal Diseases; Leukocyte Disorders; Eosinophilia; Eosinophilic Esophagitis; Esophagitis
• Other Study ID Numbers: 17-006566

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No