Use of MRI for Assessing Stomach Relaxation in Response to a Meal

Healthy Volunteers Clinical Trial

Official title:

Dynamic MRI - A Novel Approach for Measuring Gastric Accommodation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275743
• Other study ID #: 05-004022
• Status: Completed
• Phase: Phase 1
• First received: January 10, 2006
• Last updated: April 27, 2009
• Start date: October 2005
• Est. completion date: December 2008

Study information

• Verified date: April 2009
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is being done to test new way of measuring the relaxation of the stomach after a meal (called gastric accommodation) by using a MRI scan. This new test will be compared with the standard test of measuring stomach relaxation that uses radioactive tracers. These tests will be compared in healthy volunteers and people with upper abdominal symptoms (known as dyspepsia).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria for Dyspeptic patients (30 required)

• One or more of eight postprandial dyspeptic symptoms i.e. fullness, bloating, epigastric discomfort, early satiety, nausea, vomiting, belching, pain for a minimum of 3 months, OR

• Patients fulfilling the ROME-II criteria for functional dyspepsia,

• AND no symptom improvement after standard dose PPI treatment,

• AND normal upper gastrointestinal endoscopy within six months prior to the study

Inclusion Criteria for Healthy Controls (20 required)

• Absence of current abdominal symptoms or depression

Exclusion Criteria for all Participants

• Known structural upper GI disorder (e.g. peptic ulcer disease, esophagitis, malignancy);

• Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, tubal ligation, or inguinal hernia repair;

• Medications that may alter gastrointestinal motility, e.g., serotoninergic agents, alpha adrenergic agonists, calcium channel or beta blockers; stable dose of thyroxine will be permitted;

• Pregnant or breast-feeding females;

• Known claustrophobia;

• Any metal objects in the body (e.g. metal implants, pacemaker, AICD)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dyspepsia
• Healthy Volunteers

Intervention

Procedure:
• MRI

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric Volume (fasting and postprandial)
Primary	Antral Contractility