Assessing tissue stiffness in glioma patients using MRE scans
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 study is testing if special scans can measure how stiff brain tissue is in patients with gliomas and radiation damage to see how these conditions differ.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04373720 on ClinicalTrials.gov |
What this trial studies
This trial utilizes magnetic resonance elastography (MRE) to measure the stiffness of tissue affected by radiation necrosis and recurrent glioma in patients who have previously undergone treatment for gliomas. The primary objectives are to estimate the mean stiffness of lesions associated with radiation necrosis and glioma recurrence. Additionally, the study aims to compare the stiffness between these two types of lesions. Patients will undergo MRE followed by standard MRI scans, and those who require further evaluation may have a biopsy to assess disease status.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of pathology-proven intracranial glioma who have received prior chemotherapy and radiation.
Not a fit: Patients under 18 years old, pregnant, or those with certain medical conditions that prevent safe MRI procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and treatment assessments for patients with gliomas.
How similar studies have performed: Other studies using MRE for tissue characterization have shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Melissa Chen, MD — M.D. Anderson Cancer Center
- Study coordinator: Melissa Chen, MD
- Email: mchen9@mdanderson.org
- Phone: 713-745-9789
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.