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OpenTrials
Completed

NCT Number: NCT01999439

EoE(Eosinophilic Esophagitis)

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.

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan C. S. Mott Childrens Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

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.

Primary outcomes

  1. Evaluation of quantitative MRI as a diagnostic option for eosinophilic esophagitis

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2013
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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