MRI to Assess Fibrosis in Eosinophilic Esophagitis Patients

Eosinophilic Esophagitis Clinical Trial

— EoE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03446118
• Other study ID #: 17-006566
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: April 15, 2019

Study information

• Verified date: February 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Eosinophilic Esophagitis Activity Index (EEsAI)	Questionnaire developed to measure dysphagia - using the pro scoring method	1 day

External Links

•   Mayo Clinic Clinical Trials