MRI to Assess Fibrosis in Eosinophilic Esophagitis Patients (EoE)

Mayo Clinic logo

Mayo Clinic

Status

Terminated

Conditions

Eosinophilic Esophagitis

Treatments

Diagnostic Test: MRI to detect inflammation and fibrosis in subjects with EoE

Study type

Interventional

Funder types

Other

Identifiers

NCT03446118
17-006566

Details and patient eligibility

About

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

Full 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.

Enrollment

8 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

MRI to detect inflammation and fibrosis in EoE patients
Experimental group
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.
Treatment:
Diagnostic Test: MRI to detect inflammation and fibrosis in subjects with EoE

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems