Status:
RECRUITING
MRE Scan for the Assessment of Differences in Tissue Stiffness Between Radiation Necrosis and Recurrent Glioma in Patients With Previously Treated Gliomas
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Glioma
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04373720
Start Date
March 20 2020
End Date
November 1 2028
Last Update
September 5 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030