MRE Scan for the Assessment of Differences in Tissue Stiffness Between Radiation Necrosis and Recurrent Glioma in Patients With Previously Treated Gliomas

Not Applicable

Recruiting

• Conditions: Glioma
• Interventions: Procedure: Magnetic Resonance Elastography; Procedure: Magnetic Resonance Imaging

• Registration Number: NCT04373720
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 2020-03-20
• Study First Submitted: 2020-04-30
• Study First Submitted QC: 2020-04-30
• Study First Posted: 2020-05-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (MRE, standard of care MRI)	Magnetic Resonance Elastography	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.
Diagnostic (MRE, standard of care MRI)	Magnetic Resonance Imaging	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.

Primary Outcome Measures

Name	Time	Method
Mean lesion stiffness	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).

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States