About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>/=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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Magnetic Resonance Elastography
Procedure/SurgeryUndergo MRE
Magnetic Resonance Imaging
Procedure/SurgeryUndergo standard of care MRI
Treatment groups
Trial outcomes
Primary outcomes
Mean lesion stiffness
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).
Sponsors and contacts
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator