MRI to Assess Fibrosis in Eosinophilic Esophagitis Patients

NCT03446118 | Terminated

• 1 other identifier: 17-006566
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Eosinophilic Esophagitis

Keywords

EoE

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Barium Esophagram

  1 day

• Eosinophilic Esophagitis Activity Index (EEsAI)

  1 day

Study Arms (1)

MRI to detect inflammation and fibrosis in EoE patients

EXPERIMENTAL

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

Interventions

MRI to detect inflammation and fibrosis in subjects with EoE DIAGNOSTIC_TEST

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

MRI to detect inflammation and fibrosis in EoE patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jeff Fidler, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: February 26, 2018
• Study Start: March 1, 2017
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

US (1)