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
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis||Device: MRI to detect inflammation and fibrosis in subjects with EoE||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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)|
|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|
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
- 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.
- 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).
- Eosinophilic Esophagitis Activity Index (EEsAI) [ Time Frame: 1 day ]Questionnaire developed to measure dysphagia - using the pro scoring method
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
|United States, Minnesota|
|Mayo Clinic in Rochester||Not yet recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Alyssa J Johnson, CRC 507-538-0367 email@example.com|
|Contact: Crystal J. Lavey, CCRP 507-538-1361 firstname.lastname@example.org|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Debra M. Geno, CCRP 507-538-0367 email@example.com|
|Contact: Crystal J. Tholen, CRC 507-538-1361 firstname.lastname@example.org|
|Principal Investigator: David A Katzka|
|Principal Investigator:||David A Katzka||Mayo Clinic|