Clinical trial NCT03446118: MRI to Assess Fibrosis in Eosinophilic Esophagitis Patients
Official title: Assessment of Fibrotic and Inflammatory Components by MRI in Strictures Associated With Eosinophilic Esophagitis Before and After Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Eosinophilic Esophagitis
Keywords: EoE
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Measurement of distinct inflammatory and fibrotic components of the esophageal stricture in patients with eosinophilic esophagitis
timeFrame: 1 day
Secondary outcomes:
measure: Barium Esophagram
timeFrame: 1 day
measure: Eosinophilic Esophagitis Activity Index (EEsAI)
timeFrame: 1 day
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jeff Fidler, MD
role: PRINCIPAL_INVESTIGATOR
References: