MRI Brain and Stomach Imaging for Gastroparesis

Overseen By Travis Putzke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University School of Medicine

Must not be taking: Opiates, Metoclopramide, Dopamine agonists, Anticholinergics

Disqualifiers: Pregnancy, Gastroparesis, GI disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

31 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial excludes participants who are taking medications that can affect GI motility, such as opiates, metoclopramide, dopamine agonists, and anticholinergics. If you are on these medications, you may need to stop taking them to participate.

Is MRI generally safe for humans?

MRI is generally considered safe for humans, but some people may experience mild side effects like nausea or diarrhea, especially when contrast agents are used. Serious adverse events are rare, and MRI is widely used in medical practice. ^{1 2 3 4 5}

How does MRI imaging differ from other treatments for gastroparesis?

MRI imaging for gastroparesis is unique because it is a non-invasive method that can assess multiple aspects of gastric function simultaneously, unlike other tests that may require several invasive procedures. This makes it a more comprehensive and patient-friendly option for evaluating gastric motility and emptying. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment MRI scan for gastroparesis?

Research shows that MRI can effectively assess gastric motility (movement) and emptying, which are important in understanding and managing gastroparesis. MRI has been used to differentiate between patients with gastric motility disorders and healthy individuals, and it provides non-invasive measurements of gastric function. ^{6 7 8 10 11}

Who Is on the Research Team?

John M Wo, MD

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

This trial is for healthy volunteers aged 18-65 and those with gastroparesis symptoms lasting at least 12 weeks. Excluded are individuals unable to consent, allergic to pineapple, with certain medical conditions or surgeries, contraindications to MRI, or taking medications affecting GI motility.

Inclusion Criteria

I have had gastroparesis symptoms like nausea and pain for at least 12 weeks.

I am between 18 and 65 years old and in good health.

Exclusion Criteria

I have had stomach or upper intestine issues like ulcers, blockages, or certain diseases.

I have difficulty swallowing.

I am unable to understand and give consent for my own treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo MRI of the brain and upper GI tract to study the brain-gut interaction

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRI scan

Trial Overview The study tests the use of MRI scans as a non-invasive method to image the gastrointestinal tract and explore brain-gut interactions in both healthy participants and those with gastroparesis symptoms.

How Is the Trial Designed?

Group I: Healthy Volunteer Experimental Treatment 1 Intervention

This arm will enroll healthy volunteers as controls

Group II: Gastroparesis Subjects Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Indiana University School of Medicine

Lead Sponsor

Trials

194

Recruited

181,000+

Purdue University

Collaborator

Trials

239

Recruited

72,200+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Over a 10-year period, the FDA received 1568 reports of adverse events related to magnetic resonance (MR) systems, with 1548 reports analyzed, highlighting the importance of monitoring safety in MR imaging.

The most common serious injuries reported were thermal events, accounting for 59% of cases, followed by mechanical events (11%), projectile events (9%), and acoustic events (6%), indicating specific risks associated with MR environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-related FDA adverse event reports: A 10-yr review. Delfino, JG., Krainak, DM., Flesher, SA., et al.[2020]

In a study involving 148,489 patients over 10 years, gadoteric acid (Dotarem®) was found to be a safe MRI contrast agent, with only 0.3% of patients experiencing adverse events, primarily mild symptoms like nausea and vomiting.

The diagnostic effectiveness was high, with 99.8% of examinations yielding useful results and excellent or good image quality in 97.7% of cases, indicating that gadoteric acid is effective for routine MRI procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. Braun, J., Busse, R., Darmon-Kern, E., et al.[2020]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Real time high resolution magnetic resonance imaging for the assessment of gastric motility disorders. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Gastric motility and emptying assessment by magnetic resonance imaging after lung transplantation: correlation with gastric emptying scintigraphy. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging biomarkers of gastrointestinal motor function and fluid distribution. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Assessment of gastric motor function by cine magnetic resonance imaging. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Inter-observer reproducibility and analysis of gastric volume measurements and gastric emptying assessed with magnetic resonance imaging. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

MRI-related FDA adverse event reports: A 10-yr review. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

MR imaging of the small bowel with increasing concentrations of an oral osmotic agent. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Bowel MR imaging with oral Gastrografin: an experimental study with healthy volunteers. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

[Oral magnetic particles as an MR contrast medium for the gastrointestinal tract]. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Non-uniform gastric wall kinematics revealed by 4D Cine magnetic resonance imaging in humans. [2023]