Pilot Study to Assess Mean Lesion Stiffness of Radiation Necrosis and Recurrent Glioma Using Magnetic Resonance Elastography (MRE) in Patients With Previously Treated Gliomas
概览
- 阶段
- 不适用
- 干预措施
- Magnetic Resonance Elastography
- 疾病 / 适应症
- Glioma
- 发起方
- M.D. Anderson Cancer Center
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean lesion stiffness
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •\>/=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.
排除标准
- •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/1.73m
- •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
研究组 & 干预措施
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.
干预措施: Magnetic Resonance Elastography
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.
干预措施: Magnetic Resonance Imaging
结局指标
主要结局
Mean lesion stiffness
时间窗: At baseline
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).