Magnetogastrogram for Gastroparesis

Age: Any Age

Sex: Any

Trial Phase: Phase < 1

Sponsor: Vanderbilt University Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Claustrophobia, Pregnancy, Morbid obesity, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, noninvasive technique called magnetogastrogram (MGG) to study the stomach's electrical activity in individuals with and without stomach issues. The goal is to better understand conditions like gastroparesis (where the stomach empties too slowly), functional dyspepsia (persistent stomach discomfort), and chronic nausea, potentially leading to improved treatments. Suitable participants include those with diabetes experiencing gastroparesis, individuals who have had a gastrectomy (stomach removal surgery), and children with functional dyspepsia or chronic nausea. Participants will engage in a study using this innovative method to determine if it can distinguish between normal and abnormal stomach function. As an Early Phase 1 trial, this research focuses on understanding how this new technique works in people, offering participants a chance to contribute to groundbreaking advancements in stomach health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that this technique is safe for assessing gastric electrical activity?

Research has shown that the magnetogastrogram (MGG) is generally safe. This noninvasive method studies stomach activity without radiation. Similar technologies, like those used in MRIs, have a strong safety record. Most side effects from these technologies are minor and temporary, such as mild discomfort or slight dizziness.

For those considering participation in a trial involving the magnetogastrogram, this method poses no significant risks. It tracks the stomach's electrical signals to better understand various stomach issues. Studies indicate that this approach is well-tolerated, with no serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the magnetogastrogram technique because it offers a non-invasive way to understand stomach conditions like gastroparesis, which can be tricky to diagnose and manage. Unlike standard methods that might involve more invasive procedures or imaging, this technique uses magnetic fields to track stomach activity, potentially improving diagnosis accuracy and patient comfort. By applying this method to various conditions, including diabetes-related gastroparesis and functional dyspepsia, researchers hope to gain clearer insights into the stomach's functioning and improve treatment strategies.

What evidence suggests that this magnetogastrogram technique is effective for assessing gastroparesis?

This trial will evaluate the use of a test called magnetogastrogram (MGG) to identify stomach electrical activity patterns linked to various conditions. Research has shown that MGG can help detect gastroparesis, a condition affecting stomach movement, often seen in people with diabetes. In this trial, participants with gastroparesis, chronic nausea, functional dyspepsia, and those who have had part or all of their stomach removed will undergo MGG to assess its effectiveness in detecting abnormal stomach signals. Researchers are also testing MGG in control participants without gastrointestinal diseases. These promising findings suggest that MGG could be a useful tool for diagnosing and understanding various stomach issues without invasive procedures. ^{1 2 6 7 8}

Who Is on the Research Team?

Leonard A Bradshaw, PhD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for people aged 12-80 with conditions like gastroparesis, chronic nausea, or those who've had a gastrectomy. It includes diabetic patients and children with functional dyspepsia. Pregnant women, individuals over 80, those with claustrophobia, morbid obesity, cardiac arrhythmias or on anticoagulants cannot participate.

Inclusion Criteria

I am a child aged 12-17 with stomach upset not caused by any known disease.

I have had all or part of my stomach removed.

I am between 12 and 80 years old.

Exclusion Criteria

I do not have a history of heart rhythm problems, am not on blood thinners, and am under 80 years old.

You are extremely overweight and may not be able to use the current SQUID devices.

You are afraid of tight spaces and cannot stay still during the test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo noninvasive magnetogastrogram (MGG) to assess gastric electrical activity

4-6 weeks

Multiple visits for MGG recordings

Follow-up

Participants are monitored for changes in gastric electrical activity and symptoms

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnetogastrogram

Trial Overview The study tests a noninvasive technique called magnetogastrogram (MGG) to assess gastric electrical activity without radiation exposure. The goal is to distinguish normal from abnormal gastric activity which could improve treatment for stomach disorders.

How Is the Trial Designed?

Group I: Gastroparesis Experimental Treatment 1 Intervention

magnetogastrogram Diabetes with and without gastroparesis ; Idiopathic gastroparesis

Group II: Gastrectomy Experimental Treatment 1 Intervention

magnetogastrogram Total or partial gastrectomy group

Group III: Functional dyspepsia Experimental Treatment 1 Intervention

magnetogastrogram Children with functional dyspepsia

Group IV: Control participants Experimental Treatment 1 Intervention

magnetogastrogram Group without any gastrointestinal diseases.

Group V: Chronic nausea Experimental Treatment 1 Intervention

magnetogastrogram Children with chronic nausea

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Gadopentetate dimeglumine (Gd-DTPA) has been safely used in over 45 million MRI procedures since its introduction in 1988, with adverse events (AEs) reported in less than 0.01% of cases, indicating a strong safety profile.

The analysis revealed that while serious AEs accounted for only 9.3% of reports, there were significant regional differences in AE reporting, with the U.S. reporting nearly double the AEs compared to Europe, highlighting the importance of ongoing pharmacovigilance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use. Knopp, MV., Balzer, T., Esser, M., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9678406/

a clinical marker for pediatric chronic nausea - PMC We found significant reductions in postprandial dominant frequency and normogastric power, and higher levels of postprandial bradygastric power in patients with ...

2. journals.physiology.org journals.physiology.org/doi/abs/10.1152/ajpgi.00158.2022

a clinical marker for pediatric chronic nausea Our study demonstrates that multichannel MGG used in conjunction with custom HR-EGG detects key pathological signatures of functional nausea in children.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36255075/

a clinical marker for pediatric chronic nausea Our study demonstrates that multichannel MGG used in conjunction with custom HR-EGG detects key pathological signatures of functional nausea in children.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772572325000159

Noninvasive Quantification of Nausea Severity in Pediatric ... We measured the patients' nausea severity over the preceding 2 weeks (NSS score of 2–4, where 0 = no nausea; 4 = severe nausea) and nausea intensity at the time ...

5. journals.physiology.org journals.physiology.org/doi/prev/20221018-aop/abs/10.1152/ajpgi.00158.2022

a clinical marker for pediatric chronic nausea We found significant reductions in postprandial dominant frequency and normogastric power, and higher levels of postprandial bradygastric power ...

6. withpower.com withpower.com/trial/phase-gastroparesis-11-2012-8f361

Magnetogastrogram for Gastroparesis · Info for Participants The safety of magnetopharmaceuticals, like gadopentetate dimeglumine used in MRI, is generally good with most adverse effects being minor and temporary, such as ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03593811?cond=Nausea&aggFilters=status:act&viewType=Table&rank=2

Noninvasive Markers of Functional Nausea in Children | ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

8. researchgate.net researchgate.net/publication/346641965_The_effect_of_chronic_nausea_on_gastric_slow_wave_spatiotemporal_dynamics_in_children

The effect of chronic nausea on gastric slow wave ... While our previous studies have found both magnetogastrogram and HR-EGG to be reliable indicators of spatiotemporal dynamics in functional nausea patients, 9, ...