EoE(Eosinophilic Esophagitis)

NCT01999439 | Completed DMC

• 1 other identifier: HUM00080065
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis; Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Eosinophilic Esophagitis with Dysphagia

EXPERIMENTAL

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.

Procedure: Eosinophilic Esophagitis with Dysphagia

Interventions

Eosinophilic Esophagitis with Dysphagia PROCEDURE

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

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan C. S. Mott Childrens Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis; Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Ethan Smith, M.D.

  C.S. Mott Childrens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 3, 2013
• Study Start: January 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: December 16, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)