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MRI to Assess Fibrosis in Eosinophilic Esophagitis Patients (EoE)

Primary Purpose

Eosinophilic Esophagitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI to detect inflammation and fibrosis in subjects with EoE
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Eosinophilic Esophagitis focused on measuring EoE

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI to detect inflammation and fibrosis in EoE patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Eosinophilic Esophagitis Activity Index (EEsAI)
Questionnaire developed to measure dysphagia - using the pro scoring method

Full Information

First Posted
December 27, 2017
Last Updated
February 14, 2022
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03446118
Brief Title
MRI to Assess Fibrosis in Eosinophilic Esophagitis Patients
Acronym
EoE
Official Title
Assessment of Fibrotic and Inflammatory Components by MRI in Strictures Associated With Eosinophilic Esophagitis Before and After Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to lack of funding
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
EoE

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Twenty patients with eosinophilic esophagitis will be studied. Ten of these patients will have mild to moderate stricture formation (narrowed segment <8 cm in length and lumen diameter > 12mm) and 10 will have small caliber esophagus (a narrowed segment >8 cm in length with minimum diameter < 10mm). These groups will be delineated by routine barium esophagography performed in all Mayo patients with eosinophilic esophagitis during their initial clinical evaluation. Patients will then undergo an 8 week treatment with 3 mg budesonide twice daily as per routine clinical treatment with clinically indicated follow up endoscopy with esophageal biopsies to assess mucosal response. All patients will complete the EESAI dysphagia score per routine practice at Mayo. MRI of the esophagus will be performed in these patients initially and upon completion of the 8 week course of steroid therapy.
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI to detect inflammation and fibrosis in EoE patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI to detect inflammation and fibrosis in subjects with EoE
Intervention 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
Primary Outcome Measure Information:
Title
Measurement of distinct inflammatory and fibrotic components of the esophageal stricture in patients with eosinophilic esophagitis
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Barium Esophagram
Description
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).
Time Frame
1 day
Title
Eosinophilic Esophagitis Activity Index (EEsAI)
Description
Questionnaire developed to measure dysphagia - using the pro scoring method
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Fidler, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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MRI to Assess Fibrosis in Eosinophilic Esophagitis Patients

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