EoE(Eosinophilic Esophagitis)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Jonathan R. Dillman M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT01999439
First received: November 25, 2013
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Eosinophilic Esophagitis
Dysphagia
Procedure: Eosinophilic Esophagitis with Dysphagia

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Quantitative MRI Evaluation of Esophageal Remodeling/Response to Treatment in Children and Adolescents With Eosinophilic Esophagitis Presenting With Dysphagia

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Evaluation of quantitative MRI as a diagnostic option for eosinophilic esophagitis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 10
Study Start Date: January 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eosinophilic Esophagitis with Dysphagia
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

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.

Procedure: 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.

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).

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01999439

Contacts
Contact: Jonathan Dillman, M.D. 734-232-9247
Contact: James Pool, Jr., CCRC 734-615-7391 jampool@umich.edu

Locations
United States, Michigan
University of Michigan C. S. Mott Childrens Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jonathan Dillman, M.D.    734-232-9247      
Contact: James Pool Jr., CCRC    734-615-7391    jampool@umich.edu   
Principal Investigator: Jonathan Dillman, M.D.         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Jonathan Dillman, M.D. C.S. Mott Childrens Hospital
  More Information

No publications provided

Responsible Party: Jonathan R. Dillman M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01999439     History of Changes
Other Study ID Numbers: HUM00080065
Study First Received: November 25, 2013
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hematologic Diseases
Immune System Diseases
Leukocyte Disorders
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Eosinophilic Esophagitis
Esophagitis
Eosinophilia
Gastroenteritis
Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on October 23, 2014