EoE(Eosinophilic Esophagitis)
Primary Purpose
Eosinophilic Esophagitis, Dysphagia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eosinophilic Esophagitis with Dysphagia
Eosinophilic Esophagitis with Dysphagia
Sponsored by
About this trial
This is an interventional diagnostic trial for Eosinophilic Esophagitis
Eligibility Criteria
Inclusion Criteria:
- Pediatric patients ages 8 to 18 years of age.
- Pediatric patients with dysphagia(difficulty swallowing) or an episode of food impaction.
- Pediatric patients newly diagnosed with Eosinophilic Esophagitis -
Exclusion Criteria:
- Are not able to undergo an MRI without needing sedation or general anesthesia
- Are allergic to gadolinium-based contrast material
- Have an ongoing acute kidney injury
- Have chronic kidney disease with an estimated glomerular filtration rate(eGFR)of <40 ml/min.
- Have a presence of eosinophilia involving the stomach and/or esophagus.
- Have a prior history of caustic ingestion
- Have a prior history of esophageal surgery, including history of tracheoesophageal fistula.
- Have known celiac disease
- Have known Crohn's disease
- Have known malignancy
- Have hypereosinophilic syndrome
- Have recent history of parasitic infection
- Have known inflammatory bowel disease -
Sites / Locations
- University of Michigan C. S. Mott Childrens Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eosinophilic Esophagitis with Dysphagia
Arm Description
To assess quantitative magnetic resonance imaging(MRI)as a potential diagnostic tool for evaluating esophageal wall thickness and stiffness and response to treatment in children and adolescents with a diagnosis of eosinophilic esophagitis (EoE) presenting with difficulty swallowing(dysphagia)and food impaction.
Outcomes
Primary Outcome Measures
Evaluation of quantitative MRI as a diagnostic option for eosinophilic esophagitis
To assess noninvasive quantitative magnetic resonance imaging (MRI) based biomarkers in the evaluation of esophageal wall remodeling and response to treatment in children and adolescents with newly diagnosed eosinophilic esophagitis presenting with dysphagia. Magnetic resonance imaging (MRI)findings will be correlated with the endoscopic appearance of the esophagus, histologic findings, and clinical symptoms.
Secondary Outcome Measures
Full Information
NCT ID
NCT01999439
First Posted
November 25, 2013
Last Updated
December 15, 2016
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT01999439
Brief Title
EoE(Eosinophilic Esophagitis)
Official Title
Quantitative MRI Evaluation of Esophageal Remodeling/Response to Treatment in Children and Adolescents With Eosinophilic Esophagitis Presenting With Dysphagia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate quantitative magnetic resonance imaging(MRI) as a potential non-invasive, radiation-free diagnostic tool for evaluating esophageal wall remodeling (thickness and stiffness) and response to treatment in children and adolescents with newly diagnosed eosinophilic esophagitis (EoE) presenting with dysphagia (difficulty swallowing) and food impaction.
Detailed Description
Eosinophilic esophagitis(EoE) is a form of chronic inflammation affecting the esophagus which often results in wall thickening and esophageal stiffening and is associated with complications, such as esophageal tears and strictures (narrowings). Chronic dysphagia and acute food impaction (swallowed food stuck in the esophagus) are common symptoms of EoE and are associated with esophageal wall thickening and stiffness.
Current diagnostic techniques such as endoscopy with biopsy give only limited information about changes in the esophageal wall in eosinophilic esophagitis(EoE). In routine clinical practice, repeat endoscopic evaluation with biopsy is commonly performed about 3-6 months after initial therapy for eosinophilic esophagitis(EoE). However, follow-up endoscopy with biopsy has drawbacks as it is invasive, costly and typically requires deep sedation or general anesthesia.
We propose to evaluate quantitative MRI as a potential non-invasive diagnostic option for evaluating esophageal wall remodeling in patients with eosinophilic esophagitis(EoE).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis, Dysphagia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eosinophilic Esophagitis with Dysphagia
Arm Type
Experimental
Arm Description
To assess quantitative magnetic resonance imaging(MRI)as a potential diagnostic tool for evaluating esophageal wall thickness and stiffness and response to treatment in children and adolescents with a diagnosis of eosinophilic esophagitis (EoE) presenting with difficulty swallowing(dysphagia)and food impaction.
Intervention Type
Procedure
Intervention Name(s)
Eosinophilic Esophagitis with Dysphagia
Intervention Description
An upper endoscopy with biopsy at the time of diagnosis(which is a standard procedure to diagnose eosinophilic esophagitis. This will be done with sedation or general anesthesia, also a standard procedure. At the time of the anesthesia a small amount of blood will be drawn to measure markers of inflammation and fibrosis. This procedure will take approximately 45 minutes to complete. This endoscopy with biopsy will be repeated in 6 months.
Subjects will also complete a magnetic resonance imaging(MRI)scan with 2 weeks of the initial clinical endoscopy with biopsy, prior to the initiation of your medical treatment. This MRI will be repeated in 6 months. Each magnetic resonance imaging(MRI)scan will take approximately 2 hours to complete.
Intervention Type
Procedure
Intervention Name(s)
Eosinophilic Esophagitis with Dysphagia
Intervention Description
Subjects will also complete a magnetic resonance imaging(MRI)scan with 2 weeks of the initial clinical endoscopy with biopsy, prior to the initiation of your medical treatment. This MRI will be repeated in 6 months. Each magnetic resonance imaging(MRI)scan will take approximately 2 hours to complete.
Primary Outcome Measure Information:
Title
Evaluation of quantitative MRI as a diagnostic option for eosinophilic esophagitis
Description
To assess noninvasive quantitative magnetic resonance imaging (MRI) based biomarkers in the evaluation of esophageal wall remodeling and response to treatment in children and adolescents with newly diagnosed eosinophilic esophagitis presenting with dysphagia. Magnetic resonance imaging (MRI)findings will be correlated with the endoscopic appearance of the esophagus, histologic findings, and clinical symptoms.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pediatric patients ages 8 to 18 years of age.
Pediatric patients with dysphagia(difficulty swallowing) or an episode of food impaction.
Pediatric patients newly diagnosed with Eosinophilic Esophagitis -
Exclusion Criteria:
Are not able to undergo an MRI without needing sedation or general anesthesia
Are allergic to gadolinium-based contrast material
Have an ongoing acute kidney injury
Have chronic kidney disease with an estimated glomerular filtration rate(eGFR)of <40 ml/min.
Have a presence of eosinophilia involving the stomach and/or esophagus.
Have a prior history of caustic ingestion
Have a prior history of esophageal surgery, including history of tracheoesophageal fistula.
Have known celiac disease
Have known Crohn's disease
Have known malignancy
Have hypereosinophilic syndrome
Have recent history of parasitic infection
Have known inflammatory bowel disease -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ethan Smith, M.D.
Organizational Affiliation
C.S. Mott Childrens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan C. S. Mott Childrens Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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EoE(Eosinophilic Esophagitis)
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