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.
12345Is 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.
23467How 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.
13458Eligibility 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 am 18 years old or older.
I have had a brain tumor treated with chemo and radiation.
+1 more
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.
+2 more
Trial 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)
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Diagnostic (MRE, standard of care MRI)Experimental Treatment2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
High Resolution Imaging of Viscoelastic Properties of Intracranial Tumours by Multi-Frequency Magnetic Resonance Elastography. [2021]In recent years Magnetic Resonance Elastography (MRE) emerged into a clinically applicable imaging technique. It has been shown that MRE is capable of measuring global changes of the viscoelastic properties of cerebral tissue. The purpose of our study was to evaluate a spatially resolved three-dimensional multi-frequent MRE (3DMMRE) for assessment of the viscoelastic properties of intracranial tumours.
Harnessing brain waves: a review of brain magnetic resonance elastography for clinicians and scientists entering the field. [2021]Brain magnetic resonance elastography (MRE) is an imaging technique capable of accurately and non-invasively measuring the mechanical properties of the living human brain. Recent studies have shown that MRE has potential to provide clinically useful information in patients with intracranial tumors, demyelinating disease, neurodegenerative disease, elevated intracranial pressure, and altered functional states. The objectives of this review are: (1) to give a general overview of the types of measurements that have been obtained with brain MRE in patient populations, (2) to survey the tools currently being used to make these measurements possible, and (3) to highlight brain MRE-based quantitative biomarkers that have the highest potential of being adopted into clinical use within the next 5 to 10 years. The specifics of MRE methodology strategies are described, from wave generation to material parameter estimations. The potential clinical role of MRE for characterizing and planning surgical resection of intracranial tumors and assessing diffuse changes in brain stiffness resulting from diffuse neurological diseases and altered intracranial pressure are described. In addition, the emerging technique of functional MRE, the role of artificial intelligence in MRE, and promising applications of MRE in general neuroscience research are presented.
Magnetic Resonance Elastography in Intracranial Neoplasms: A Scoping Review. [2022]Magnetic resonance elastography (MRE) allows noninvasive assessment of intracranial tumor mechanics and may thus be predictive of intraoperative conditions. Variations in the use of technical terms complicate reading of current literature, and there is need of a review using consolidated nomenclature.
Magnetic resonance elastography of brain tumors: preliminary results. [2007]To investigate the potential value of magnetic resonance elastography (MRE) in evaluating the consistency of brain tumors.
REVIEW: MR elastography of brain tumors. [2021]MR elastography allows non-invasive quantification of the shear modulus of tissue, i.e. tissue stiffness and viscosity, information that offers the potential to guide presurgical planning for brain tumor resection. Here, we review brain tumor MRE studies with particular attention to clinical applications. Studies that investigated MRE in patients with intracranial tumors, both malignant and benign as well as primary and metastatic, were queried from the Pubmed/Medline database in August 2018. Reported tumor and normal appearing white matter stiffness values were extracted and compared as a function of tumor histopathological diagnosis and MRE vibration frequencies. Because different studies used different elastography hardware, pulse sequences, reconstruction inversion algorithms, and different symmetry assumptions about the mechanical properties of tissue, effort was directed to ensure that similar quantities were used when making inter-study comparisons. In addition, because different methodologies and processing pipelines will necessarily bias the results, when pooling data from different studies, whenever possible, tumor values were compared with the same subject's contralateral normal appearing white matter to minimize any study-dependent bias. The literature search yielded 10 studies with a total of 184 primary and metastatic brain tumor patients. The group mean tumor stiffness, as measured with MRE, correlated with intra-operatively assessed stiffness of meningiomas and pituitary adenomas. Pooled data analysis showed significant overlap between shear modulus values across brain tumor types. When adjusting for the same patient normal appearing white matter shear modulus values, meningiomas were the stiffest tumor-type. MRE is increasingly being examined for potential in brain tumor imaging and might have value for surgical planning. However, significant overlap of shear modulus values between a number of different tumor types limits applicability of MRE for diagnostic purposes. Thus, further rigorous studies are needed to determine specific clinical applications of MRE for surgical planning, disease monitoring and molecular stratification of brain tumors.
Magnetic resonance elastography to estimate brain stiffness: Measurement reproducibility and its estimate in pseudotumor cerebri patients. [2023]This study determines the reproducibility of magnetic resonance elastography (MRE) derived brain stiffness in normal volunteers and compares it against pseudotumor patients before and after lumbar puncture (LP). MRE was performed on 10 normal volunteers for reproducibility and 14 pseudotumor patients before and after LP. During LP, opening and closing cerebrospinal fluid (CSF) pressures were recorded before and after removal of CSF and correlated to brain stiffness. Stiffness reproducibility was observed (r > 0.78; p
Vibration safety limits for magnetic resonance elastography. [2021]Magnetic resonance elastography (MRE) has been demonstrated to have potential as a clinical tool for assessing the stiffness of tissue in vivo. An essential step in MRE is the generation of acoustic mechanical waves within a tissue via a coupled mechanical driver. Motivated by an increasing volume of human imaging trials using MRE, the objectives of this study were to audit the vibration amplitude of exposure for our IRB-approved human MRE studies, to compare these values to a conservative regulatory standard for vibrational exposure and to evaluate the applicability and implications of this standard for MRE. MRE displacement data were examined from 29 MRE exams, including the liver, brain, kidney, breast and skeletal muscle. Vibrational acceleration limits from a European Union directive limiting occupational exposure to whole-body and extremity vibrations (EU 2002/44/EC) were adjusted for time and frequency of exposure, converted to maximum displacement values and compared to the measured in vivo displacements. The results indicate that the vibrational amplitudes used in MRE studies are below the EU whole-body vibration limit, and the EU guidelines represent a useful standard that could be readily accepted by Institutional Review Boards to define standards for vibrational exposures for MRE studies in humans.
Higher-Resolution Magnetic Resonance Elastography in Meningiomas to Determine Intratumoral Consistency. [2018]Magnetic resonance elastography (MRE) analyzes shear wave movement through tissue to determine stiffness. In a prior study, measurements with first-generation brain MRE techniques correlated with intraoperative observations of overall meningioma stiffness.