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Magnetic Resonance Imaging of the Brain and Stomach in Healthy Volunteers and Gastroparesis

Primary Purpose

Gastroparesis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MRI scan

About this trial

This is an interventional health services research trial for Gastroparesis focused on measuring Gastroparesis, functional MRI, Gastric MRI, Brain MRI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

HEALTHY VOLUNTEERS

Inclusion Criteria:

• Healthy volunteers from 18 to 65 years of age

Exclusion Criteria:

Contraindication to MR scanning: pregnancy, implanted gastric stimulator, neural stimulator, implanted cardiac pacemaker, auto-defibrillator, cochlear implant, ocular foreign body (e.g. metal shavings), pain pump, insulin pump or any pre-existing eye conditions.
Presence of gastroparesis symptoms, such as nausea, emesis, early satiety, effortless regurgitation, post-prandial fullness and pain, and/or postprandial epigastric pain.
Prior diagnosis of the upper GI disorders, including gastroparesis, gastric or duodenal ulcer, gastric outlet obstruction, acute or chronic pancreatitis, large hiatal or paraesophageal hernia, small intestinal bacterial overgrowth, celiac disease, Crohn's disease.
Prior systemic disorders associated with GI neuromuscular disorder listed in Appendix B.
Taking medications that can effect GI motility, including opiate, metoclopramide, dopamine agonist for Parkinson or restless leg syndrome, anticholinergics.
Prior brain or abdominal surgery (except cholecystectomy or appendectomy).
Prior diagnosis of central nervous system illness, neurological lesion, a psychiatric history, or recurrent migraines that require medication.
Uncontrolled medical problems, such as hypertension, pulmonary or airway disease, heart failure, or coronary artery disease.
Allergy to pineapple.
Presence of dysphagia.
Unable to give own informed consent.

GASTROPARESIS PATIENTS

Inclusion Criteria:

Patients with gastroparesis from 18 to 65 years of age.
Symptoms of gastroparesis of at least 12 weeks duration with varying degrees of nausea, emesis, early satiety, effortless regurgitation, post-prandial fullness and pain, and/or postprandial epigastric pain.
Abnormal 4-hour gastric emptying scintigraphy within the last 6 months >60% retention at 2 hrs and/or >10% retention at 4 hrs.

Exclusion Criteria:

Contraindication to MR scanning: pregnancy, implanted gastric stimulator, neural stimulator, implanted cardiac pacemaker, auto-defibrillator, cochlear implant, ocular foreign body (e.g. metal shavings), pain pump, insulin pump or any pre-existing eye conditions.
Prior diagnosis of the upper GI disorders other than gastroparesis, including gastric or duodenal ulcer, gastric outlet obstruction, acute or chronic pancreatitis, large hiatal or paraesophageal hernia, small intestinal bacterial overgrowth, celiac disease, Crohn's disease .
Prior brain or abdominal surgery (except cholecystectomy or appendectomy).
Prior diagnosis of central nervous system illness, neurological lesion, a psychiatric history, or recurrent migraines that require medication.
Uncontrolled medical problems, such as hypertension, pulmonary or airway disease, heart failure, or coronary artery disease.
Allergy to pineapple.
Prior history of dysphagia.
Unable to give own informed consent.

Sites / Locations

Indiana University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Healthy Volunteer

Gastroparesis Subjects

Arm Description

This arm will enroll healthy volunteers as controls

This arm will enroll a) patients with gastroparesis from type 1 diabetes and b) patients with gastroparesis from vagus nerve trauma

Outcomes

Primary Outcome Measures

Gastric peristalsis

Compare 3D gastric peristalsis progression before & after test meals in healthy volunteers and patients with gastroparesis

Secondary Outcome Measures

Contraction frequency

Compare colored 3-D heat map of stomach contraction frequency before & after test meals in healthy volunteers and patients with gastroparesis

Pylorus transit

Compare pylorus mean opening diameter before & after test meals in healthy volunteers and patients with gastroparesis

Full Information

NCT ID

NCT04282317

First Posted

December 19, 2019

Last Updated

February 11, 2022

Sponsor

Indiana University School of Medicine

Collaborators

Purdue University, National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT04282317

Brief Title

Magnetic Resonance Imaging of the Brain and Stomach in Healthy Volunteers and Gastroparesis

Official Title

Magnetic Resonance Imaging of the Brain and the Upper Gastrointestinal Tract in Healthy Volunteers and Patients With Gastroparesis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University School of Medicine

Collaborators

Purdue University, National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study is to lay the groundwork for non invasive imaging of the GI tract and the brain gut interaction

Detailed Description

Magnetic resonance imaging (MRI) produces non-invasive exquisite spatial resolution of internal organs. However, its application to the GI tract has been limited by several challenges. The GI tract has a complex and convoluted geometry. The GI geometry changes slowly over the course of meal digestion, as well as rapidly due to contraction of various compartments of the GI tract. As a person takes natural breaths during MRI, the respiratory motion further complicates the acquisition and analysis of GI images. In addition, different types of meal or nutrients have variable property as image contrast in upper GI MRI. It is difficult to standardize the MRI analysis for accurate and quantitative assessment of gastric emptying, motility, absorption, and secretion, to name a few. In a recently published study by our research collaborators at Purdue University, they have addressed many of these challenges in rodents and are ready to refine and translate their technical solutions to human upper GI MRI. Functional MRI of the brain has been used to study afferent response in various GI disorders, such as dysphagia, functional dyspepsia, and irritable bowel syndrome.1-3 Brain activity is altered in the emotional response areas, and activity is reduced in the areas associated with top-down modulation of visceral afferent signals.4 However, direct correlation between regional brain activation by functional-MRI and GI motility by meal-contrast MRI is lacking. The outcome of the proposed research is expected to lay the groundwork for non-invasive imaging of GI anatomy and function and the brain-gut interaction towards better understanding, diagnosis, prevention, and treatment of GI disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroparesis

Keywords

Gastroparesis, functional MRI, Gastric MRI, Brain MRI

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy Volunteer

Arm Type

Other

Arm Description

This arm will enroll healthy volunteers as controls

Arm Title

Gastroparesis Subjects

Arm Type

Other

Arm Description

This arm will enroll a) patients with gastroparesis from type 1 diabetes and b) patients with gastroparesis from vagus nerve trauma

Intervention Type

Other

Intervention Name(s)

MRI scan

Intervention Description

MRI scan

Primary Outcome Measure Information:

Title

Gastric peristalsis

Description

Compare 3D gastric peristalsis progression before & after test meals in healthy volunteers and patients with gastroparesis

Time Frame

Baseline

Secondary Outcome Measure Information:

Title

Contraction frequency

Description

Compare colored 3-D heat map of stomach contraction frequency before & after test meals in healthy volunteers and patients with gastroparesis

Time Frame

Baseline

Title

Pylorus transit

Description

Compare pylorus mean opening diameter before & after test meals in healthy volunteers and patients with gastroparesis

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

HEALTHY VOLUNTEERS Inclusion Criteria: • Healthy volunteers from 18 to 65 years of age Exclusion Criteria: Contraindication to MR scanning: pregnancy, implanted gastric stimulator, neural stimulator, implanted cardiac pacemaker, auto-defibrillator, cochlear implant, ocular foreign body (e.g. metal shavings), pain pump, insulin pump or any pre-existing eye conditions. Presence of gastroparesis symptoms, such as nausea, emesis, early satiety, effortless regurgitation, post-prandial fullness and pain, and/or postprandial epigastric pain. Prior diagnosis of the upper GI disorders, including gastroparesis, gastric or duodenal ulcer, gastric outlet obstruction, acute or chronic pancreatitis, large hiatal or paraesophageal hernia, small intestinal bacterial overgrowth, celiac disease, Crohn's disease. Prior systemic disorders associated with GI neuromuscular disorder listed in Appendix B. Taking medications that can effect GI motility, including opiate, metoclopramide, dopamine agonist for Parkinson or restless leg syndrome, anticholinergics. Prior brain or abdominal surgery (except cholecystectomy or appendectomy). Prior diagnosis of central nervous system illness, neurological lesion, a psychiatric history, or recurrent migraines that require medication. Uncontrolled medical problems, such as hypertension, pulmonary or airway disease, heart failure, or coronary artery disease. Allergy to pineapple. Presence of dysphagia. Unable to give own informed consent. GASTROPARESIS PATIENTS Inclusion Criteria: Patients with gastroparesis from 18 to 65 years of age. Symptoms of gastroparesis of at least 12 weeks duration with varying degrees of nausea, emesis, early satiety, effortless regurgitation, post-prandial fullness and pain, and/or postprandial epigastric pain. Abnormal 4-hour gastric emptying scintigraphy within the last 6 months >60% retention at 2 hrs and/or >10% retention at 4 hrs. Exclusion Criteria: Contraindication to MR scanning: pregnancy, implanted gastric stimulator, neural stimulator, implanted cardiac pacemaker, auto-defibrillator, cochlear implant, ocular foreign body (e.g. metal shavings), pain pump, insulin pump or any pre-existing eye conditions. Prior diagnosis of the upper GI disorders other than gastroparesis, including gastric or duodenal ulcer, gastric outlet obstruction, acute or chronic pancreatitis, large hiatal or paraesophageal hernia, small intestinal bacterial overgrowth, celiac disease, Crohn's disease . Prior brain or abdominal surgery (except cholecystectomy or appendectomy). Prior diagnosis of central nervous system illness, neurological lesion, a psychiatric history, or recurrent migraines that require medication. Uncontrolled medical problems, such as hypertension, pulmonary or airway disease, heart failure, or coronary artery disease. Allergy to pineapple. Prior history of dysphagia. Unable to give own informed consent.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anita Gupta, MBBS,MPH

Phone

317-278-0406

anigupta@iu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Travis Putzke

Phone

317-278-2064

tputzke@iu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John M Wo, MD

Organizational Affiliation

Indiana University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Indiana University School of Medicine

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anita Gupta, MBBS, MPH

Phone

317-278-0406

anigupta@iu.edu

First Name & Middle Initial & Last Name & Degree

Travis Putzke, BS

Phone

317-278-2064

tputzke@iu.edu

First Name & Middle Initial & Last Name & Degree

John M Wo, MD

First Name & Middle Initial & Last Name & Degree

Kristine M Mosier, MD

12. IPD Sharing Statement

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Magnetic Resonance Imaging of the Brain and Stomach in Healthy Volunteers and Gastroparesis

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