Diagnostic Accuracy of Dynamic Susceptibility Contrast (DSC) Perfusion MRI to Determine Radiation Necrosis Versus Tumor Progression in Brain Metastases Treated With Stereotactic Radiosurgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: mean transit time (MTT)
研究概览
简要总结
This trial studies how well dynamic susceptibility contrast-magnetic resonance imaging (MRI) works in determining radiation necrosis and tumor progression in participants with cancer that has spread to the brain and are being treated with radiation therapy. Diagnostic procedures, such as dynamic susceptibility contrast-MRI, may improve the ability to determine indeterminate post-treatment changes seen on imaging after radiation therapy.
详细描述
PRIMARY OBJECTIVE:
I. To prospectively determine the sensitivity and specificity of dynamic susceptibility contrast (DSC)-MRI parameters in detecting tumor recurrence versus radiation necrosis for brain metastases treated with stereotactic radiosurgery (SRS).
SECONDARY OBJECTIVES:
I. To correlate radiographic diagnoses with pathologic diagnoses when surgical resection is clinically indicated.
II. To correlate baseline relative cerebral blood volume (rCBV) values and other hemodynamic parameters with tumor primary histology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven diagnosis of invasive malignancy with at least radiographic evidence of intracranial disease as seen on MRI.
- •At least one identifiable intracranial lesion ≥ 1 cm in diameter enrolled within 4 weeks of diagnosis.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.
排除标准
- •Planned whole-brain radiotherapy (WBRT) with boost.
- •Leptomeningeal disease.
- •Inadequate renal function (estimated glomerular filtration rate [eGFR] > 30 ml/min/1.73 m²) or contrast allergy.
- •Non-MRI compatible pacemaker with pacemaker dependence.
研究组 & 干预措施
Diagnostic (MRI, DSC-MRI)
Participants undergo diagnostic magnetic resonance imaging (MRI) with and without contrast and treatment planning dynamic susceptibility contrast-MRI (DSC-MRI) series before receiving SRS at 4-6 weeks after SRS, and then every 3 months unless clinically indicated sooner.
干预措施: Dynamic Susceptibility Contrast-MRI (DSC-MRI) (Procedure)
Diagnostic (MRI, DSC-MRI)
Participants undergo diagnostic magnetic resonance imaging (MRI) with and without contrast and treatment planning dynamic susceptibility contrast-MRI (DSC-MRI) series before receiving SRS at 4-6 weeks after SRS, and then every 3 months unless clinically indicated sooner.
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
结局指标
主要结局
Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: mean transit time (MTT)
时间窗: Baseline up to 1 year
Image processing will occur in a blinded manner using nordicICE software (NordicNeuroLab AS, Bergen, Norway). Signal-intensity curves will be created per voxel. Regions of interest will be designated around the contrast enhancing lesion as seen on T1-post contrast MR. An additional contralateral area of normal-appearing white matter will be designated in the same axial plane to standardize the data. MTT is defined as the average time in which contrast passes through a given region of brain tissue and is estimated from the contrast concentration-time course curve (CC-TCC) as width of the curve at half maximum height.
Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: relative cerebral blood volume (rCBV)
时间窗: Baseline up to 1 year
Image processing will occur in a blinded manner using nordicICE software (NordicNeuroLab AS, Bergen, Norway). Signal-intensity curves will be created per voxel. Regions of interest will be designated around the contrast enhancing lesion as seen on T1-post contrast MR. An additional contralateral area of normal-appearing white matter will be designated in the same axial plane to standardize the data. rCBV is calculated as the ratio of the CBV within the enhancing region to the CBV within the contralateral normal-appearing white matter.
Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: percentage of signal intensity recovery (PSR)
时间窗: Baseline up to 1 year
Image processing will occur in a blinded manner using nordicICE software (NordicNeuroLab AS, Bergen, Norway). Signal-intensity curves will be created per voxel. Regions of interest will be designated around the contrast enhancing lesion as seen on T1-post contrast MR. An additional contralateral area of normal-appearing white matter will be designated in the same axial plane to standardize the data. PSR is defined as the percentage of the difference between lowest signal intensity during contrast bolus and the recovery post-contrast signal intensity compared to the peak height.
Change in dynamic susceptibility contrast (DSC)-magnetic resonance imaging (MRI) parameters: relative peak height (rPH)
时间窗: Baseline up to 1 year
Image processing will occur in a blinded manner using nordicICE software (NordicNeuroLab AS, Bergen, Norway). Signal-intensity curves will be created per voxel. Regions of interest will be designated around the contrast enhancing lesion as seen on T1-post contrast MR. An additional contralateral area of normal-appearing white matter will be designated in the same axial plane to standardize the data. rPH is defined as the maximal change in contrast signal intensity from pre-contrast baseline compared to the lowest signal intensity during contrast bolus, normalized to the signal in the contralateral normal-appearing white matter.
次要结局
未报告次要终点
研究者
Hui-Kuo Shu
Principal Investigator
Emory University