EoE(Eosinophilic Esophagitis)

Dysphagia Clinical Trial

Official title:

Quantitative MRI Evaluation of Esophageal Remodeling/Response to Treatment in Children and Adolescents With Eosinophilic Esophagitis Presenting With Dysphagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999439
• Other study ID #: HUM00080065
• Status: Completed
• Phase: N/A
• First received: November 25, 2013
• Last updated: December 15, 2016
• Start date: January 2014
• Est. completion date: April 2016

Study information

• Verified date: December 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Pediatric patients ages 8 to 18 years of age.

2. Pediatric patients with dysphagia(difficulty swallowing) or an episode of food impaction.

3. Pediatric patients newly diagnosed with Eosinophilic Esophagitis -

Exclusion Criteria:

1. Are not able to undergo an MRI without needing sedation or general anesthesia

2. Are allergic to gadolinium-based contrast material

3. Have an ongoing acute kidney injury

4. Have chronic kidney disease with an estimated glomerular filtration rate(eGFR)of <40 ml/min.

5. Have a presence of eosinophilia involving the stomach and/or esophagus.

6. Have a prior history of caustic ingestion

7. Have a prior history of esophageal surgery, including history of tracheoesophageal fistula.

8. Have known celiac disease

9. Have known Crohn's disease

10. Have known malignancy

11. Have hypereosinophilic syndrome

12. Have recent history of parasitic infection

13. Have known inflammatory bowel disease -

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Eosinophilic Esophagitis
• Esophagitis

Intervention

Procedure:
• Eosinophilic Esophagitis with Dysphagia
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.
• Eosinophilic Esophagitis with Dysphagia
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.

Locations

Country	Name	City	State
United States	University of Michigan C. S. Mott Childrens Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	Yes