Magnetic Resonance Elastography for Hydrocephalus

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Neuro-stimulator, Pacemaker, Coagulopathy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

35 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this project is to assess the utility of a new magnetic resonance technique called magnetic resonance elastography (MRE) in the non-invasive diagnosis of normal pressure hydrocephalus. The investigators hypothesize that MRE produces a unique imaging signature for hydrocephalus that distinguishes the disease from the normal (non-hydrocephalic) but atrophied brain, a distinction not possible with conventional MR imaging studies that are presently available.

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 or your doctor.

Is Magnetic Resonance Elastography (MRE) safe for humans?

Magnetic Resonance Elastography (MRE) is generally considered safe when proper safety guidelines are followed, as most reported injuries with MR procedures are due to not following these guidelines. The technology has evolved to be safer, and adverse events are rare when guidelines are adhered to. ^{1 2 3 4 5}

How does Magnetic Resonance Elastography differ from other treatments for hydrocephalus?

Magnetic Resonance Elastography (MRE) is unique because it is a noninvasive imaging technique that measures the stiffness of brain tissue, which can help assess changes in hydrocephalus patients. Unlike traditional treatments that focus on relieving pressure, MRE provides detailed information about brain mechanics, potentially aiding in diagnosis and treatment planning. ^{6 7 8 9 10}

Research Team

Keith D Paulsen, PhD

Principal Investigator

Dartmouth College

Eligibility Criteria

This trial is for adults over 21 with adult onset hydrocephalus, which includes conditions like normal pressure hydrocephalus. Participants should have symptoms such as memory issues, urinary incontinence, or walking problems and enlarged ventricles on brain scans. It's not for those with pacemakers, pregnancy, severe organ dysfunction or diseases that make surgery too risky.

Inclusion Criteria

You are older than 21 years old.

You have been diagnosed with hydrocephalus that started in adulthood.

You have experienced memory loss, urinary incontinence, or trouble walking that is getting worse.

Exclusion Criteria

You have a device like a neuro-stimulator or a cardiac pacemaker implanted in your body.

Pregnancy

You have a known blood clotting problem or a major problem with one of your organs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRE Assessment

Participants undergo magnetic resonance elastography (MRE) to assess the utility of this technique in diagnosing normal pressure hydrocephalus

1-2 weeks

Follow-up

Participants are monitored for clinical improvement and changes in shear modulus after VP shunting

15 years

Treatment Details

Interventions

• Magnetic Resonance Elastography

Trial Overview The study tests a new MRI technique called magnetic resonance elastography (MRE) to see if it can better identify hydrocephalus compared to standard MRI by looking for unique patterns in the brain that indicate the disease.

Participant Groups

Group I: MRE Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Findings from Research

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]

Recent advancements in magnetic resonance (MR) technology have led to stronger magnetic fields and improved safety features, but most MR-related injuries and fatalities are due to non-compliance with safety guidelines.

To enhance safety in MR environments, it is crucial to update and revise safety information regarding biological effects and the compatibility of biomedical implants and devices with current MR technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR procedures: biologic effects, safety, and patient care. Shellock, FG., Crues, JV.[2008]

In a study of 1334 cardiovascular magnetic resonance (CMR) procedures for patients with congenital heart disease, the overall incidence of adverse events (AEs) was low at 1.6%, with most being minor in severity.

The use of general anesthesia and the status of being an inpatient were identified as independent risk factors for experiencing AEs, particularly in the most critically ill patients, highlighting the need for careful monitoring in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. Dorfman, AL., Odegard, KC., Powell, AJ., et al.[2013]

In a study of 72,839 patients undergoing gadolinium-enhanced cardiac magnetic resonance imaging, the incidence of acute adverse events (AAEs) was low at 0.36%, with severe AAEs occurring in only 0.033% of cases.

AAE rates were influenced by factors such as the type of gadolinium-based contrast agent used, the presence of pharmacological stress during imaging, and the specific indications for the imaging, with higher rates observed during stress imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients. Uhlig, J., Lücke, C., Vliegenthart, R., et al.[2021]

Magnetic resonance elastography (MRE) using high-density array coils allows for the acquisition of high-resolution images of tissue mechanical properties with significantly reduced scan times, demonstrating its efficacy in capturing shear wave propagation.

The study successfully demonstrated the ability to visualize changes in mechanical properties of agar samples in real-time, indicating that this advanced MRE technique could be beneficial for non-repeatable or destructive testing scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploration of highly accelerated magnetic resonance elastography using high-density array coils. Bosshard, JC., Yallapragada, N., McDougall, MP., et al.[2020]

The spin-echo echo-planar imaging (SE-EPI) sequence for magnetic resonance elastography (MRE) provides highly reproducible and repeatable measurements of intervertebral disc stiffness, showing excellent correlation with the standard gradient recalled echo (GRE) technique.

SE-EPI significantly reduces scan times by at least 51% compared to GRE, making it a more efficient option for assessing the mechanical properties of intervertebral discs in healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Elastography of Intervertebral Discs: Spin-Echo Echo-Planar Imaging Sequence Validation. Co, M., Dong, H., Boulter, DJ., et al.[2023]

Magnetic resonance elastography (MRE) has shown promise in predicting the mechanical properties of intracranial tumors, such as consistency and adhesiveness, which could inform intraoperative conditions.

Despite its potential, MRE is still in the preclinical stage, with current studies being limited by small and variable sample sizes, highlighting the need for larger cohorts and standardized techniques for future clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Elastography in Intracranial Neoplasms: A Scoping Review. Aunan-Diop, JS., Halle, B., Pedersen, CB., et al.[2022]

References

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

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

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

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

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

MR procedures: biologic effects, safety, and patient care. [2008]

4. England pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. [2013]

5. Germany pubmed.ncbi.nlm.nih.gov

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients. [2021]

6. China pubmed.ncbi.nlm.nih.gov

Exploration of highly accelerated magnetic resonance elastography using high-density array coils. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

MR Elastography demonstrates reduced white matter shear stiffness in early-onset hydrocephalus. [2021]

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

Magnetic Resonance Elastography of Intervertebral Discs: Spin-Echo Echo-Planar Imaging Sequence Validation. [2023]

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

Magnetic Resonance Elastography in Intracranial Neoplasms: A Scoping Review. [2022]

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

Magnetic resonance elastography in normal pressure hydrocephalus-a scoping review. [2023]