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

ConditionGlioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>/=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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Magnetic Resonance Elastography

    Procedure/Surgery

    Undergo MRE

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo standard of care MRI

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Diagnostic (MRE, standard of care MRI)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Mean lesion stiffness

For each patient, a lesion region of interest (ROI) will be created along with its normal appearing contralateral white matter. The stiffness of the tumor ROI and the contralateral white matter ROI will be measured, and the ratios of the stiffness between the two will be calculated. Interval estimates will be computed for mean stiffness ratio in patients with radiation necrosis or glioma recurrence, separately using a 2-sided 95% confidence interval. Outcome variable of stiffness will be assessed between tumor and contralateral white matter with paired t-tests or Wilcoxon signed-rank tests. The Wilcoxon rank-sum test or t-tests will be used to assess the associations between the outcome variable of stiffness ratio and tumor status (recurrence/necrosis).

Time frame
At baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator