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

NCT04373720 | Recruiting

• 2 other identifiers: 2019-1070NCI-2020-02247
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• 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).

  At baseline

Study Arms (1)

Diagnostic (MRE, standard of care MRI)

EXPERIMENTAL

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.

Procedure: Magnetic Resonance Elastography; Procedure: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Elastography PROCEDURE

Undergo MRE

Also known as: MRE

Diagnostic (MRE, standard of care MRI)

Magnetic Resonance Imaging PROCEDURE

Undergo standard of care MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Diagnostic (MRE, standard of care MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>/=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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Glioma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Melissa Chen, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Chen, MD

CONTACT

713-745-9789; mchen9@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 4, 2020
• Study Start: March 20, 2020
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)