Overview

This trial is active, not recruiting.

Conditions eosinophilic esophagitis, dysphagia
Treatments eosinophilic esophagitis with dysphagia
Sponsor University of Michigan
Start date January 2014
End date December 2017
Trial size 10 participants
Trial identifier NCT01999439, HUM00080065

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(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.
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.

Primary Outcomes

Measure
Evaluation of quantitative MRI as a diagnostic option for eosinophilic esophagitis
time frame: 2 years

Eligibility Criteria

Male or female participants from 8 years up to 18 years old.

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 -

Additional Information

Official title Quantitative MRI Evaluation of Esophageal Remodeling/Response to Treatment in Children and Adolescents With Eosinophilic Esophagitis Presenting With Dysphagia
Principal investigator Jonathan Dillman, M.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Michigan.