Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04373720

Conditions

Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnetic Resonance Elastography

Magnetic Resonance Imaging

Study Details

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

Study ID

NCT04373720

Start date

Mar 20, 2020

Status verified date

Mar, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Nov 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Magnetic Resonance Elastography

Undergo MRE

Magnetic Resonance Imaging

Undergo standard of care MRI

Primary outcome measure

  • Mean lesion stiffness [ Time Frame: At baseline ]

Central Contacts and Locations

Central contacts

Melissa Chen, MD

713-745-9789mchen9@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Melissa Chen, MD

713-745-9789

Principal Investigator:

Melissa Chen

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-03-05.