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MRI to Assess Fibrosis in Eosinophilic Esophagitis Patients (EoE)

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ClinicalTrials.gov Identifier: NCT03446118
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Device: MRI to detect inflammation and fibrosis in subjects with EoE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Fibrotic and Inflammatory Components by MRI in Strictures Associated With Eosinophilic Esophagitis Before and After Treatment
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : July 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MRI to detect inflammation and fibrosis in EoE patients
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.
Device: 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




Primary Outcome Measures :
  1. Measurement of distinct inflammatory and fibrotic components of the esophageal stricture in patients with eosinophilic esophagitis [ Time Frame: 1 day ]
    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 :
  1. Barium Esophagram [ Time Frame: 1 day ]
    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).

  2. Eosinophilic Esophagitis Activity Index (EEsAI) [ Time Frame: 1 day ]
    Questionnaire developed to measure dysphagia - using the pro scoring method



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446118


Locations
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United States, Minnesota
Mayo Clinic in Rochester Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Alyssa J Johnson, CRC    507-538-0367    johnson.alyssa@mayo.edu   
Contact: Crystal J. Lavey, CCRP    507-538-1361    lavey.crystal@mayo.edu   
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Debra M. Geno, CCRP    507-538-0367    geno.debra@mayo.edu   
Contact: Crystal J. Tholen, CRC    507-538-1361    tholen.crystal@mayo.edu   
Principal Investigator: David A Katzka         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: David A Katzka Mayo Clinic
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Responsible Party: David A. Katzka, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03446118    
Other Study ID Numbers: 17-006566
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by David A. Katzka, Mayo Clinic:
EoE
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases