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

NCT ID: NCT04373720

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-20
• Study Completion Date: 2028-11-01

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.

Conditions

Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Magnetic Resonance Elastography

Intervention Type: PROCEDURE

Undergo MRE

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo standard of care MRI

Interventions

Magnetic Resonance Elastography

Undergo MRE

Intervention Type: PROCEDURE

Magnetic Resonance Imaging

Undergo standard of care MRI

Intervention Type: PROCEDURE

Other Intervention Names

MRE; Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR Imaging; MRI; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Chen, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Melissa Chen, MD

Role: CONTACT

mchen9@mdanderson.org

713-745-9789

Facility Contacts

Melissa Chen, MD

Role: primary

713-745-9789

MD

Role: backup

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2020-02247

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-1070

Identifier Type: OTHER

Identifier Source: secondary_id

2019-1070

Identifier Type: -

Identifier Source: org_study_id