MRE Scan for Brain Tumor Assessment

Overseen By Melissa Chen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnant, Renal failure, Pacemakers, others

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

Compensation: Varies

Number of Visits: 2

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses magnetic resonance elastography (MRE) to estimate tissue stiffness (hardness or softness of the tissue) in tissue that is affected by radiation treatment (radiation necrosis) and tumor tissue that has come back (recurrent) after treatment in patients with gliomas. Diagnostic procedures, such as MRE, may estimate the differences in tissue stiffness between radiation necrosis and recurrent glioma post treatment and ultimately lead to a more accurate diagnosis and/or surgery, and/or a better assessment of the disease's response to treatment.

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 data supports the effectiveness of the treatment Magnetic Resonance Elastography (MRE) for brain tumor assessment?

Research shows that Magnetic Resonance Elastography (MRE) can measure the stiffness of brain tumors, which may help in planning surgeries. MRE has been found to correlate with the stiffness of certain types of brain tumors, like meningiomas, during surgery, suggesting it could be useful for surgical planning. ^{1 2 3 4 5}

Is Magnetic Resonance Elastography (MRE) safe for humans?

Research indicates that the vibration levels used in Magnetic Resonance Elastography (MRE) are below the safety limits set by the European Union for whole-body vibrations, suggesting it is generally safe for human use. ^{2 3 4 6 7}

How is the treatment Magnetic Resonance Elastography (MRE) unique for brain tumor assessment?

Magnetic Resonance Elastography (MRE) is unique because it non-invasively measures the stiffness and viscosity of brain tumors, which can help in planning surgeries by providing detailed information about the tumor's consistency. This approach is different from traditional imaging techniques that primarily focus on the size and shape of tumors. ^{1 3 4 5 8}

Research Team

Melissa Chen

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with a history of gliomas treated with chemo and radiation, who have a lesion larger than 2 cm. Participants must understand and consent to the study. It excludes pregnant individuals, those allergic to gadolinium-based contrast agents, people with severe kidney issues or GFR <30mL/min/1.73m^2, and anyone with non-MR safe implants or conditions.

Inclusion Criteria

My brain lesion is larger than 2 cm.

I have had a brain tumor treated with chemo and radiation.

I understand the study and agree to participate.

Exclusion Criteria

Pregnant

Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to: electronically, magnetically, and mechanically activated implants, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers, metallic splinters in the eye, ferromagnetic hemostatic clips in the central nervous system (CNS) or body, cochlear implants, other pacemakers, e.g., for the carotid sinus, insulin pumps and nerve stimulators, non-MR safe lead wires, prosthetic heart valves (if dehiscence is suspected), non-ferromagnetic stapedial implants, claustrophobia that does not readily respond to oral medication

My kidney function is low, with a GFR under 30 mL/min.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic

Participants undergo MRE and standard of care MRI to assess tissue stiffness

Baseline

1 visit (in-person)

Follow-up

Participants undergo standard of care MRI to check the status of the disease

4-8 weeks

1 visit (in-person)

Treatment Details

Interventions

• Magnetic Resonance Elastography
• Magnetic Resonance Imaging

Trial Overview The trial tests Magnetic Resonance Elastography (MRE) alongside MRI to measure tissue stiffness in areas affected by radiation treatment versus recurrent tumor tissues in glioma patients. The goal is more accurate diagnoses and assessments of treatment response.

Participant Groups

Group I: Diagnostic (MRE, standard of care MRI) Experimental Treatment 2 Interventions

Patients undergo MRE over 10 minutes and then undergo standard of care MRI of the brain with and without contrast at baseline. Within 4 weeks after the initial MRI and MRE scans, patients may undergo standard of care biopsy to check the status of the disease. Within 48 hours after biopsy, patients undergo standard of care MRI to check the status of the disease. Patients who do not undergo biopsy undergo standard of care MRI 4-8 weeks after MRE scan to check the status of the disease.

Magnetic Resonance Elastography is already approved in United States, European Union for the following indications:

Approved in United States as Magnetic Resonance Elastography for:

• Diagnostic imaging for gliomas
• Assessment of tissue stiffness in radiation necrosis and recurrent glioma

Approved in European Union as Magnetic Resonance Elastography for:

• Diagnostic imaging for gliomas
• Assessment of tissue stiffness in radiation necrosis and recurrent glioma

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Magnetic Resonance Elastography (MRE) can effectively assess the viscoelastic properties of intracranial tumors, providing valuable insights into their mechanical characteristics, as demonstrated in a study involving 27 patients.

The study found that meningiomas could be clearly distinguished from other tumor types based on their viscoelastic properties, while glioblastomas and other intraaxial tumors showed overlapping characteristics, indicating potential for improved tumor characterization using MRE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Resolution Imaging of Viscoelastic Properties of Intracranial Tumours by Multi-Frequency Magnetic Resonance Elastography. Reiss-Zimmermann, M., Streitberger, KJ., Sack, I., et al.[2021]

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) 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) was tested on six patients with solid brain tumors to evaluate its effectiveness in assessing tumor consistency before surgery.

The results showed that MRE accurately reflected the actual consistency of the tumors as confirmed during surgical evaluation, suggesting it could be a valuable noninvasive imaging technique for brain tumor assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance elastography of brain tumors: preliminary results. Xu, L., Lin, Y., Han, JC., et al.[2007]

MR elastography (MRE) is a promising non-invasive technique that quantifies tissue stiffness, which can aid in presurgical planning for brain tumor resections, as shown in a review of 10 studies involving 184 patients.

While MRE demonstrated a correlation between tumor stiffness and intra-operative assessments, the significant overlap in stiffness values among different tumor types suggests that more research is needed to refine its diagnostic applications and enhance its utility in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

REVIEW: MR elastography of brain tumors. Bunevicius, A., Schregel, K., Sinkus, R., 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

High Resolution Imaging of Viscoelastic Properties of Intracranial Tumours by Multi-Frequency Magnetic Resonance Elastography. [2021]

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

Harnessing brain waves: a review of brain magnetic resonance elastography for clinicians and scientists entering the field. [2021]

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

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

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

Magnetic resonance elastography of brain tumors: preliminary results. [2007]

5. Netherlands pubmed.ncbi.nlm.nih.gov

REVIEW: MR elastography of brain tumors. [2021]

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

Magnetic resonance elastography to estimate brain stiffness: Measurement reproducibility and its estimate in pseudotumor cerebri patients. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Vibration safety limits for magnetic resonance elastography. [2021]

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

Higher-Resolution Magnetic Resonance Elastography in Meningiomas to Determine Intratumoral Consistency. [2018]