Dysphagia Clinical Trial
Official title:
Quantitative MRI Evaluation of Esophageal Remodeling/Response to Treatment in Children and Adolescents With Eosinophilic Esophagitis Presenting With Dysphagia
Verified date | December 2016 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 18 Years |
Eligibility |
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 - |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan C. S. Mott Childrens Hospital | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
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