Pilot Study of Dynamic Contrast Enhanced Computed Tomography (DCE-CT) Imaging for the Assessment of Radiation Therapy Outcome for Liver Cancer Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- DCE-CT Perfusion Metrics: Blood Volume
研究概览
简要总结
This is a pilot study that uses a standard of care technique, Stereotactic Body Radiation Therapy (SBRT), in combination with Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to determine if perfusion changes from SBRT of liver cancer may be used for outcome assessment and prediction of prognosis.
详细描述
Patients will undergo standard of care SBRT while also receiving DCE-CT, also known as perfusion CT, pre-treatment, 6 hours post-treatment and 6 weeks post-treatment.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision to sign and date the consent form
- •Stated willingness to comply with all study procedures and be available for the duration of the study
- •Be a Male or Female aged 18-100
- •Diagnosed with Liver HCC or metastases
- •Must be receiving or will plan to receive SBRT for Liver HCC or metastases
排除标准
- •Allergy to iodine contrast
- •CT with contrast not offered as a Standard of Care
- •Pregnant women
结局指标
主要结局
DCE-CT Perfusion Metrics: Blood Volume
时间窗: Baseline to end of follow-up, up to 12 weeks
Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through blood volume as shown through DCE-CT imaging.
DCE-CT Perfusion Metrics: K-Trans
时间窗: Baseline to end of follow-up, up to 12 weeks
Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through K-Trans (extraction-flow product) as shown through DCE-CT imaging.
DCE-CT Perfusion Metrics: Blood Flow
时间窗: Baseline to end of follow-up, up to 12 weeks
Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through blood flow as shown through DCE-CT imaging.
次要结局
- Correlation Between Patient Demographics and Blood Volume: Age(Post follow-up to end of study, up to 12 months)
- Correlation Between Patient Demographics and Blood Flow: Sex(Post follow-up to end of study, up to 12 months)
- Correlation Between Patient Demographics and K-Trans: Sex(Post follow-up to end of study, up to 12 months)
- Correlation Between Patient Demographics and K-Trans: Age(Post follow-up to end of study, up to 12 months)
- Correlation Between Patient Demographics and K-Trans: Clinical Stage of Disease(Post follow-up to end of study, up to 12 months)
- Correlation Between Patient Demographics and K-Trans: Race(Post follow-up to end of study, up to 12 months)
- Correlation Between Patient Demographics and Blood Volume: Sex(Post follow-up to end of study, up to 12 months)
- Correlation Between Patient Demographics and Blood Volume: Clinical Stage of Disease(Post follow-up to end of study, up to 12 months)
- Correlation Between Patient Demographics and Blood Flow: Age(Post follow-up to end of study, up to 12 months)
- Correlation Between Patient Demographics and Blood Flow: Race(Post follow-up to end of study, up to 12 months)
- Correlation Between Patient Demographics and Blood Volume: Race(Post follow-up to end of study, up to 12 months)
- Correlation Between Patient Demographics and Blood Flow: Clinical Stage of Disease(Post follow-up to end of study, up to 12 months)