MRE Scan for the Assessment of Differences in Tissue Stiffness Between Radiation Necrosis and Recurrent Glioma in Patients With Previously Treated Gliomas
March 3, 2026 updated by: M.D. Anderson Cancer Center
Pilot Study to Assess Mean Lesion Stiffness of Radiation Necrosis and Recurrent Glioma Using Magnetic Resonance Elastography (MRE) in Patients With Previously Treated Gliomas
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To estimate the mean lesion stiffness in patients with radiation necrosis using magnetic resonance elastography (MRE).
II. To estimate the mean lesion stiffness in patients with glioma recurrence using magnetic resonance elastography (MRE).
SECONDARY OBJECTIVE:
I. To investigate the mean lesion stiffness between radiation necrosis and glioma recurrence.
OUTLINE:
Patients undergo MRE over 10 minutes and then undergo standard of care magnetic resonance imaging (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.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Melissa Chen, MD
- Phone Number: 713-745-9789
- Email: mchen9@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Principal Investigator:
- Melissa Chen
-
Contact:
- MD
-
Contact:
- Melissa Chen, MD
- Phone Number: 713-745-9789
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- >/=18 years old.
- History of a pathology proven intracranial glioma (including IDH mutant, IDH wildtype or 1p19q co-deleted tumors) treated with chemotherapy and radiation.
- The lesion of concern (T2 Flair Hyperintense or contrast enhancing lesion) is > 2 cm
- Patient is able to understand and give consent to participation in the study.
Exclusion Criteria
- Patients less than 18 years of age.
- Pregnant.
- Known allergy to gadolinium-based contrast agents.
- Renal failure as evidenced by a glomerular filtration rate (GFR) of less than 30 mL/min/1.73m2.
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diagnostic (MRE, standard of care MRI)
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.
|
Undergo standard of care MRI
Other Names:
Undergo MRE
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean lesion stiffness
Time Frame: At baseline
|
For each patient, a lesion region of interest (ROI) will be created along with its normal appearing contralateral white matter.
The stiffness of the tumor ROI and the contralateral white matter ROI will be measured, and the ratios of the stiffness between the two will be calculated.
Interval estimates will be computed for mean stiffness ratio in patients with radiation necrosis or glioma recurrence, separately using a 2-sided 95% confidence interval.
Outcome variable of stiffness will be assessed between tumor and contralateral white matter with paired t-tests or Wilcoxon signed-rank tests.
The Wilcoxon rank-sum test or t-tests will be used to assess the associations between the outcome variable of stiffness ratio and tumor status (recurrence/necrosis).
|
At baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Melissa Chen, MD, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2020
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2028
Study Registration Dates
First Submitted
April 30, 2020
First Submitted That Met QC Criteria
April 30, 2020
First Posted (Actual)
May 4, 2020
Study Record Updates
Last Update Posted (Actual)
March 5, 2026
Last Update Submitted That Met QC Criteria
March 3, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-1070 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-02247 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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