Clinical trial NCT01999439: EoE(Eosinophilic Esophagitis)
Official title: Quantitative MRI Evaluation of Esophageal Remodeling/Response to Treatment in Children and Adolescents With Eosinophilic Esophagitis Presenting With Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eosinophilic Esophagitis
Dysphagia
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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 -

Primary outcomes:
measure: Evaluation of quantitative MRI as a diagnostic option for eosinophilic esophagitis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan C. S. Mott Childrens Hospital
state: Michigan
Study officials:
affiliation: C.S. Mott Childrens Hospital
name: Ethan Smith, M.D.
role: PRINCIPAL_INVESTIGATOR
References: