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

22 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Magnetogastrogram for gastroparesis?

The study on magnetogastrography (MGG) shows that it is a reliable technique for measuring gastric emptying, which is relevant for gastroparesis as this condition involves delayed gastric emptying. ^{1 2 3 4 5}

Is the Magnetogastrogram safe for humans?

The safety of magnetopharmaceuticals, like gadopentetate dimeglumine used in MRI, is generally good with most adverse effects being minor and temporary, such as nausea and vomiting. Severe reactions are rare, occurring in about 1 in 350,000 to 450,000 cases, and are less common than with other contrast agents. ^{6 7 8 9 10}

How does the magnetogastrogram treatment for gastroparesis differ from other treatments?

The magnetogastrogram (MGG) treatment for gastroparesis is unique because it is a non-invasive method that evaluates gastric magnetic field activity, unlike traditional methods that assess electrical activity and are affected by body mass index. MGG provides reliable and reproducible measurements of gastric emptying, making it a promising alternative to the current gold standard, scintigraphy, for assessing gastric motility. ^{2 11 12 13 14}

What is the purpose of this trial?

There is a tremendous clinical need for a noninvasive technique that can assess gastric electrical activity and would be repeatable without any exposure to radiation. Investigators developed a new technique allowing to use noninvasive methods to assess bioelectrical activity in the gastrointestinal system. This has enabled to characterize the normal and pathologic physiology of the stomach through the use of noninvasive magnetogastrogram (MGG) records. Primary hypothesis for this proposal is that analysis of gastric slow wave uncoupling and propagation in multichannel MGG discriminates between normal and pathological gastric electrical activity. Eventually, investigators envision this research leading to new insights for gastrointestinal conditions such as gastroparesis, functional dyspepsia and chronic idiopathic nausea that would inform clinical management of these debilitating diseases.

Research Team

Leonard A Bradshaw, PhD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Factors contributing to hospitalization for gastroparesis exacerbations. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Magnetogastrography (MGG) reproducibility assessments of gastric emptying on healthy subjects. [2013]

3. Turkey pubmed.ncbi.nlm.nih.gov

Assessment of the Prevalence of Diabetic Gastroparesis and Validation of Gastric Emptying Scintigraphy for Diagnosis. [2020]

4. Greece pubmed.ncbi.nlm.nih.gov

Clinical predictors of symptom improvement failure in gastroparesis. [2022]

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

Comparison between the widely used magnetically controlled capsule gastroscopy and conventional gastroscopy: a meta-analysis. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

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

7. Japan pubmed.ncbi.nlm.nih.gov

Safety of gadopentetate dimeglumine after 120 million administrations over 25 years of clinical use. [2019]

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

Magnetic resonance contrast agents for neuroimaging. Safety issues. [2015]

9. United States 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. [2015]

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

Contrast-Induced Vomiting in Pediatric Patients Under Propofol Sedation: A Case Series. [2020]

11. China pubmed.ncbi.nlm.nih.gov

Effect of Body Mass Index on the sensitivity of Magnetogastrogram and Electrogastrogram. [2020]

12. Argentina pubmed.ncbi.nlm.nih.gov

Gender difference in the gastric emptying measured by magnetogastrography using a semi-solid test meal. [2009]

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

Effects of magnetogastrography sensor configurations in tracking slow wave propagation. [2022]

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

Scintigraphy vs. mechanical magnetogastrography: gastric emptying analysis. [2021]