Response Assessment for External Beam Radiation Therapy in Spinal Metastasis of Hepatocellular Carcinoma (HCC): Usefulness of Diffusion-Weighted Magnetic Resonance (MR) Imaging as A Functional Imaging
试验速览
- 阶段
- 2 期
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- oral morphine equivalent doseresponse criteria
研究概览
简要总结
Recently, diffusion-weighted (DW) MR imaging has widened its application on various oncologic applications. Especially, it is expected the DW MRI could provide valuable information about early response evaluation after treatment using rapid apparent diffusion coefficient (ADC) value change. It has demonstrated potential usefulness in response evaluation in the liver tumors after treatments such as transarterial chemoembolization (TACE) and radiation therapy (RT). Furthermore, it is a functional imaging technique that does not require a contrast agent, it can be safely used in patients with renal insufficiency or other medical contraindications for contrast agents.
The optimal assessment of early response of RT could provide one of the most important information to prescribe patient and cancer specific RT dose. It might be also important in palliative RT of HCC bone metastasis which is related with painful aggressive mass formation.
This study is performed to evaluate the usefulness of DW MRI in early response evaluation after RT for HCC bone metastasis.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatocellular carcinoma
- •Spine metastasis
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- •20 or older age
- •informed consent
- •consent to birth control during 6 months after treatment
排除标准
- •less than 12 weeks of expected survival
- •indication of emergency operation
- •uncontrolled ascites or encephalopathy
- •previous RT field lesion (within in 1 month)
研究组 & 干预措施
EBRT
干预措施: External beam radiation therapy (Radiation)
结局指标
主要结局
oral morphine equivalent doseresponse criteria
时间窗: 3 months after RT completion
Degree of pain will be assessed via Visual Analog Scale for Pain (VAS).
次要结局
- Quality of Life(3 months after RT completion)
- Overall survival(From RT start to the date up to 24 weeks)
- Modified Response Evaluation Criteria in Solid Tumor(3 months after RT completion)
- Time to local tumor progression(From RT start to the date up to 24 weeks)
研究者
Jong Won Kwon
Assistant Professor
Samsung Medical Center