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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04373720
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Melissa Chen, MD
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

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

Procedure: - Magnetic Resonance Elastography

Undergo MRE

Procedure: - Magnetic Resonance Imaging

Undergo standard of care MRI

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Melissa Chen, MD

[email protected]

713-745-9789

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