MR Elastography for Intracranial Hypertension

Overseen By Jacqueline A. Leavitt, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Age <18, Pregnancy, MR contraindications

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

Compensation: Varies

Number of Visits: 2

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to detect increased pressure inside the skull, known as intracranial hypertension. It focuses on using MR elastography, which researchers might compare to other noninvasive methods like special eye scans or brain imaging. Participants will undergo various procedures, including standard imaging and possibly a lumbar puncture (also known as a spinal tap). Individuals with conditions like papilledema (swelling of the optic nerve) due to high brain pressure, as well as those without this issue, might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance diagnostic techniques for intracranial hypertension.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that MR elastography is safe for detecting intracranial hypertension?

Research has shown that MR elastography is a safe and noninvasive method. Studies have found that patients tolerate it well. This technique uses imaging to assess tissue stiffness, aiding in diagnosis without surgery. No major problems have been reported from MR elastography, making it a promising imaging choice.

Lumbar punctures, by contrast, are a common procedure for collecting fluid from around the spine for testing. They are generally safe, though some people may experience temporary side effects like headaches or back pain. Serious issues are rare.

In summary, both MR elastography and lumbar punctures are considered safe. MR elastography is noninvasive and well tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MR elastography for intracranial hypertension because it offers a new, non-invasive way to evaluate brain pressure and tissue stiffness that could complement or even reduce the need for more invasive procedures like lumbar punctures. Unlike traditional methods that often rely on measuring cerebrospinal fluid pressure directly, MR elastography uses magnetic resonance imaging to visualize the mechanical properties of brain tissue. This could provide a safer, more comfortable experience for patients while offering detailed insights into changes within the brain that are related to increased intracranial pressure. The potential to gather comprehensive data without invasive techniques is a promising advancement in managing and understanding intracranial hypertension.

What evidence suggests that MR elastography is effective for detecting raised intracranial pressure?

Research shows that MR elastography (MRE), a method used in this trial, can measure brain tissue stiffness, potentially aiding in assessing skull pressure. Studies have found that MRE is non-invasive, providing crucial details about brain stiffness without surgery or body entry. This information might indicate changes in skull pressure. MRE offers a less intrusive alternative to direct pressure measurement. Previous research successfully used MRE to measure both overall and specific brain stiffness. In this trial, MRE is evaluated as a promising alternative to more invasive methods like lumbar punctures for assessing intracranial pressure. ^{3 6 7 8 9}

Who Is on the Research Team?

John J Chen, M.D., Ph.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with conditions like idiopathic intracranial hypertension or obstructive hydrocephalus, which cause increased pressure inside the skull. It's also for those without such pressure issues to serve as a comparison group. People can't join if they're under 18, pregnant, or have conditions that make MR imaging unsafe for them.

Inclusion Criteria

You do not have increased pressure inside your head.

Everyone who participates must meet the following requirements.

You have swelling of the optic nerve due to high pressure inside your head.

Exclusion Criteria

People who should not have an MRI.

Age <18

You are pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants undergo MR elastography, MRI, OCT imaging, and optic nerve B-scan ultrasound to establish baseline measurements

1-2 weeks

1 visit (in-person)

Intervention

Participants may receive interventions such as lumbar punctures, medications, or surgical interventions to lower intracranial pressure

Varies based on intervention

Follow-up

Participants are monitored for changes in brain stiffness and other measurements after interventions

1-2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lumbar puncture
• MR elastography
• MRI structural brain imaging
• Optical Coherence Tomography (OCT) imaging
• Optic nerve B-scan ultrasound

Trial Overview

The study tests how well MR elastography can measure raised intracranial pressure compared to other noninvasive methods like OCT imaging of retinal nerve fibers and MRI signs. Participants will undergo these imaging techniques along with lumbar punctures and optic nerve ultrasounds.

How Is the Trial Designed?

Group I: Patients with increased intracranial hypertension Experimental Treatment 5 Interventions

Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture.

Group II: Patient without raised intracranial hypertension Experimental Treatment 4 Interventions

Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, and Optic nerve B-scan ultrasound. Some patients will receive lumbar punctures.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Published Research Related to This Trial

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]

Magnetic resonance elastography (MRE) demonstrated high sensitivity (75%) and specificity (100%) for detecting intratumoral heterogeneity in meningiomas, indicating its potential as a reliable preoperative diagnostic tool.

MRE effectively identified soft tumor portions with 100% sensitivity, but was less reliable for ruling out hard portions, especially in smaller or more vascular tumors, suggesting that while MRE is promising, its accuracy may vary based on tumor characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher-Resolution Magnetic Resonance Elastography in Meningiomas to Determine Intratumoral Consistency. Hughes, JD., Fattahi, N., Van Gompel, J., et al.[2018]

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]

Brain magnetic resonance elastography (MRE) is a non-invasive imaging technique that can measure the mechanical properties of the brain, providing valuable information for diagnosing conditions like tumors and neurodegenerative diseases.

MRE has the potential to become a key clinical tool in the next 5 to 10 years, particularly for planning surgeries and assessing changes in brain stiffness due to various neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing brain waves: a review of brain magnetic resonance elastography for clinicians and scientists entering the field. Arani, A., Manduca, A., Ehman, RL., 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]

Magnetic resonance elastography (MRE) is a promising imaging technique that quantifies tissue consistency, which could enhance the diagnosis and treatment of conditions like meningiomas and normal pressure hydrocephalus.

While MRE shows potential benefits in neurosurgery and neuroscience, its direct clinical application is still developing, indicating a need for further research to fully realize its value in medical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetic resonance elastography of the brain]. Aunan-Diop, JS., Pedersen, CB., Jensen, U., et al.[2021]

Magnetic resonance elastography (MRE) demonstrated good reproducibility in measuring brain stiffness, with a correlation coefficient of r > 0.78, indicating reliable results in normal volunteers.

In patients with pseudotumor, brain stiffness was significantly higher during opening lumbar puncture compared to normal volunteers, suggesting potential diagnostic value, although no correlation was found between cerebrospinal fluid pressures and brain stiffness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance elastography to estimate brain stiffness: Measurement reproducibility and its estimate in pseudotumor cerebri patients. Kolipaka, A., Wassenaar, PA., Cha, S., et al.[2023]

In a study of 29 MRE exams across various tissues, the vibrational amplitudes used in magnetic resonance elastography (MRE) were found to be below the European Union's safety limits for whole-body vibrations, indicating a safe application for human studies.

The findings support the use of EU regulatory standards as a benchmark for vibrational exposure in MRE, which could help Institutional Review Boards establish safety guidelines for future human imaging trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibration safety limits for magnetic resonance elastography. Ehman, EC., Rossman, PJ., Kruse, SA., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5811891/

Acute pressure changes in the brain are correlated with ...

MR elastography (MRE) is capable of noninvasively measuring brain tissue stiffness in vivo, and may act as a surrogate to measure ICP. The objective of this ...

2.

nature.com

nature.com/articles/s41598-024-57250-4

Feasibility of assessing non-invasive intracranial ...

Magnetic resonance elastography (MRE) quantifies brain stiffness by measuring the shear modulus. Our objective is to investigate the ...

3.

jnis.bmj.com

jnis.bmj.com/content/16/Suppl_1/A173.1

E-145 Revolutionizing the evaluation of neurological ...

MR elastography (MRE) is a non-invasive imaging technique to assess brain tissue stiffness. The incorporation of this can provide valuable information about the ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35822642/

Features of Idiopathic Intracranial Hypertension on MRI With ...

Brain stiffness, as assessed by MR elastography (MRE), may reflect changes in ICP. OBJECTIVE. The purpose of this study was to compare pituitary ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1053811917308212

MR elastography of the brain and its application in ...

Magnetic resonance elastography (MRE) noninvasively measures tissue stiffness. · MRE can reliably measure global and regional stiffness in the brain in vivo.

6.

ajnr.org

ajnr.org/content/early/2024/03/14/ajnr.A8162

Evaluation of MR Elastography as a Noninvasive ...

Results from this pilot study demonstrate MR elastography as a potential imaging biomarker and a noninvasive method for diagnosing spontaneous intracranial ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06916715

MR Elastography in Intracranial Lesions: Feasibility & ...

Conventional MR imaging lacks sensitivity to differentiating tumor grades, while magnetic resonance elastography (MRE) offers non-invasive assessment potential.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0079656524000116

Magnetic resonance elastography in a nutshell

Magnetic resonance elastography (MRE) is an emerging clinical imaging modality for characterizing the viscoelastic properties of soft biological tissues.

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11086054/

Clinical application of magnetic resonance elastography in ...

MR elastography is noninvasive, well tolerated, and complements standard radiological and histopathological studies by providing in vivo measurements.