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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method called magnetic resonance elastography (MRE) to help diagnose normal pressure hydrocephalus, a condition that can cause memory problems, trouble walking, or loss of bladder control. Researchers believe MRE can reveal unique brain patterns that current MRI scans cannot. Adults experiencing symptoms such as memory loss, difficulty walking, or urinary issues, and who have a specific type of brain swelling visible on scans, might be suitable candidates for this study. As an unphased study, this trial offers patients the opportunity to contribute to groundbreaking research that could enhance diagnostic methods.

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.

What prior data suggests that this magnetic resonance technique is safe for diagnosing hydrocephalus?

Research has shown that Magnetic Resonance Elastography (MRE) is generally safe when safety guidelines are followed. This imaging method is non-invasive, meaning it doesn't involve surgery or entering the body.

Studies have found that MRE can provide important information about brain conditions like hydrocephalus without causing harm. The available research reports no major side effects, suggesting that patients tolerate MRE well.

Overall, MRE appears to be a safe way to diagnose conditions like normal pressure hydrocephalus, offering a promising alternative to more invasive procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Magnetic Resonance Elastography (MRE) is unique because it offers a non-invasive way to measure brain tissue stiffness, which can be crucial for diagnosing and monitoring hydrocephalus. Unlike the standard invasive procedures like lumbar punctures and ventriculoperitoneal shunting, MRE provides a clear picture of how brain tissue behaves without needing surgery. Researchers are excited about this technique because it could lead to earlier and more accurate diagnosis, potentially improving patient outcomes and reducing the need for more invasive tests.

What evidence suggests that magnetic resonance elastography is effective for diagnosing hydrocephalus?

Research has shown that Magnetic Resonance Elastography (MRE), which participants in this trial will undergo, might help diagnose normal pressure hydrocephalus. Studies have found that MRE can detect changes in brain stiffness, a key factor in this condition. People with normal pressure hydrocephalus have stiffer brains than healthy individuals. This unique imaging feature could help distinguish normal pressure hydrocephalus from other brain conditions that appear similar on regular MRI scans. Overall, MRE offers a promising, non-invasive method to better understand and diagnose this condition. ^{1 2 3 6 7}

Who Is on the Research Team?

Keith D Paulsen, PhD

Principal Investigator

Dartmouth College

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11286123/

Prediction of Surgical Outcomes in Normal Pressure ... CONCLUSIONS: MR elastography provides further insight into mechanical alterations in the normal pressure hydrocephalus brain and is a promising, noninvasive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4792773/

MR Elastography Demonstrates Increased Brain Stiffness ... This study demonstrates increased brain stiffness in patients with normal pressure hydrocephalus compared with age- and sex-matched healthy controls.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213158221000231

MR Elastography demonstrates reduced white matter ... Brain stiffness is reduced in hydrocephalus patients compared to healthy controls, and is associated with clinically-relevant functional outcome measures.

4. mayo.edu mayo.edu/research/clinical-trials/cls-20314942

MR Elastography of Hydrocephalus We are doing this research study to develop and test the effectiveness of a new imaging technique called magnetic resonance elastography (MRE).

5. ajnr.org ajnr.org/content/early/2015/11/05/ajnr.A4560

MR Elastography Demonstrates Increased Brain Stiffness ... CONCLUSIONS: This study demonstrates increased brain stiffness in patients with normal pressure hydrocephalus compared with age- and sex-matched ...

6. fluidsbarrierscns.biomedcentral.com fluidsbarrierscns.biomedcentral.com/articles/10.1186/2045-8118-12-S1-O38

Magnetic resonance elastography demonstrates increased ... MRE demonstrated significantly increased parenchymal stiffness among NPH patients as compared to normal controls in multiple ROIs, including the ...

7. withpower.com withpower.com/trial/phase-hydrocephalus-2-2007-2b9dd

Magnetic Resonance Elastography for Hydrocephalus Is Magnetic Resonance Elastography (MRE) safe for humans? Magnetic Resonance Elastography (MRE) is generally considered safe when proper safety guidelines ...