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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how MRI scans (Magnetic Resonance Imaging) can reveal the connection between the stomach and the brain, especially in individuals with gastroparesis. Gastroparesis is a condition where the stomach cannot empty properly, causing symptoms like nausea and early satiety. The trial includes two groups: one with gastroparesis patients, including those with type 1 diabetes or nerve damage, and a second group of healthy volunteers for comparison. Healthy individuals with no history of stomach issues or major surgeries may be suitable candidates. As an unphased trial, this study allows participants to contribute to groundbreaking research that could enhance the understanding and treatment of gastroparesis.

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.

What prior data suggests that MRI is safe for brain and stomach imaging?

Research shows that MRI (magnetic resonance imaging) scans are generally safe and easy to manage. Studies have found that MRI can effectively assess stomach functions, such as emptying and movement, without invasive procedures. This technology aids in understanding stomach functions in both healthy individuals and those with conditions like gastroparesis, which slows or stops food movement from the stomach to the small intestine.

MRI scans do not use radiation, enhancing their safety. Reports of serious side effects from MRI scans are rare. However, some people might feel uncomfortable or anxious inside the MRI machine due to its enclosed space and loud noises. This feeling is common and not specific to research settings.

In summary, MRI scans have a strong safety record in both medical research and everyday use. Their widespread use provides confidence in their safety for anyone considering joining this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this MRI imaging technique for gastroparesis because it offers a non-invasive way to understand the condition better. Unlike standard treatments like dietary changes, medications, or surgical interventions that focus on symptom relief, this MRI approach aims to provide detailed images of the brain and stomach. By capturing these images, researchers hope to uncover new insights into how gastroparesis develops, particularly in patients with type 1 diabetes or those with vagus nerve trauma. This could lead to more targeted and effective treatments in the future.

What evidence suggests that MRI is effective for imaging gastroparesis?

Research has shown that MRI scans can effectively track stomach movement and emptying. In this trial, participants with gastroparesis, due to either type 1 diabetes or vagus nerve trauma, will undergo MRI scans to assess stomach emptying. Healthy volunteers will also be scanned as controls. For people with gastroparesis, the stomach often takes longer to empty compared to those without the condition. One study found that MRI can clearly show these differences, aiding doctors in understanding and monitoring the condition. Another study highlighted that MRI is a reliable and non-invasive method to observe how the stomach empties food. These findings suggest that MRI might be useful for better diagnosing and understanding gastroparesis. ^{1 3 6 7 8}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1774201/

Real time high resolution magnetic resonance imaging for ... Results: Patients with gastroparesis showed a lower motility index compared with the reference volunteer group while the mean motility index of the patient ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002927099004487

Evaluation of gastric emptying and motility in diabetic ... Emptying was slower in the gastroparetic patients (t1/2: 124 ± 10 min) compared to patients with normal emptying (81 ± 9 min, p < 0.05). Cisapride accelerated ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10078537/

Magnetic resonance imaging as a non‐invasive tool to ... Our data indicate that MRI is a reliable and reproducible tool to assess gastric emptying in mice and represents a useful technique to study ...

4. mdpi.com mdpi.com/2075-1729/13/8/1743

Imaging in Gastroparesis: Exploring Innovative Diagnostic ... Reclassification based on GES results at the 48-week follow-up showed that 42% of initially diagnosed GP patients had normal GE, while 37% of initially defined ...

5. biorxiv.org biorxiv.org/content/10.1101/2020.12.11.421743v1.full-text

Automatic Assessment of Human Gastric Motility and ... Gastric volume decreased 34.64±2.8% over 1 hour where the emptying followed a linear-exponential pattern. The gastric motility showed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10455809/

Imaging in Gastroparesis: Exploring Innovative Diagnostic ... GP is diagnosed by objectively documenting gastric emptying (GE) delays using gastric emptying scintigraphy (GES) with a standardized test meal to assess ...

7. mdpi.com mdpi.com/2624-5647/2/2/6

Status of Brain Imaging in Gastroparesis Gastroparesis is a chronic debilitating disorder characterized by slowed gastric emptying with accompanying symptoms thereof in the absence of ...

8. cghjournal.org cghjournal.org/article/S1542-3565(09)00371-1/pdf

CLINICAL IMAGING Evaluation of gastric emptying and motility in diabetic gastroparesis with magnetic resonance imaging: effects of cisapride. Am J Gastroenterol. 1999;94:2866 – ...