Quantitative MR Imaging Methods for Functional Assessment Following Stereotactic Body Radiation Therapy for Spinal Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Relative Change in Sequence specific parameters for Diffusion weighted imaging (DWI)
研究概览
简要总结
The purpose of this study is to determine if quantitative magnetic resonance imaging (qMRI) can objectively measure changes in the tumor/vertebral body and adjacent spinal cord following stereotactic body radiation therapy (SBRT) for painful metastatic spine disease.
详细描述
Metastatic spine disease (MSD) can result in considerable morbidity from pain, spinal cord compromise and neurologic disability. Recent developments in image-guidance and immobilization have enabled more accurate target localization, which allows methods of precise high-dose radiation delivery such as stereotactic body radiation therapy (SBRT). SBRT carries potential risks of radiation induced myelopathy (RIM) and vertebral compression fracture (VCF). Magnetic resonance imaging (MRI) is a sensitive imaging modality that may be able to detect radiation-induced damage in the vertebral body or spinal cord following SBRT. Quantitative MR-based imaging methods may also help to quantify treatment response and help predict subsequent outcomes such as tumor control and VCF risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •A diagnosis of metastatic cancer with a vertebral body metastasis or contiguous vertebral body metastases for which SBRT is appropriate
- •Age ≥ 18 years of age
- •Life expectancy of at least 3 months
- •No contraindication to undergoing MR imaging
- •Women of childbearing age must have a negative urine or serum pregnancy test to meet eligibility per Duke Policy
- •Pre-treatment pain score of at least 1/10 based on the numeric pain rating scale (NPRS)
- •Disease located from C1 to S5
- •Subjects with prior radiation to the involved vertebral body are allowed.
排除标准
- •Subjects unable to undergo MRI (includes non-MRI compatible material or devices and severe claustrophobia)
- •Subjects with prior procedural intervention to the involved vertebral body that would result in artifact (kyphoplasty, screw and/or rod placement); minimally invasive surgery without instrumentation of the involved vertebral body and instrumentation immediately above or below the index lesion is allowed.
- •Subjects with spinal cord compression; minimally invasive "separation" surgery to first resect the epidural component is allowed
- •Pregnant or breast-feeding women
- •Allergy to standard IV contrast agents used in MRI
- •Subjects with eGFR <30 30 mL/min2 or on dialysis
结局指标
主要结局
Relative Change in Sequence specific parameters for Diffusion weighted imaging (DWI)
时间窗: baseline, 4 wks
Relative Change in Sequence specific parameters for Diffusion tensor imaging (DTI)
时间窗: baseline, 4 wks
Relative Change in Sequence specific parameters for Dynamic contrast enhanced (DCE) MRI
时间窗: baseline, 4 wks
次要结局
- Change in numeric pain score as measured by the Numeric Pain Rating Scale(baseline, 4 wks)
- Change in opioid use(baseline, 4 wks)
- Change in numeric pain score as measured by the EQ5D Pain Questionnaire(baseline, 4 wks)
- Change in numeric pain score as measured by the Brief Pain Inventory(baseline, 4 wks)
- Change in quality of life as measured by the Pat Sf36 V2 assessment(baseline, 4 wks)
- Change in quality of life as measured by the SOSG+ assessment(baseline, 4 wks)
- Change in quality of life as measured by the PROMIS assessment(baseline, 4 wks)