4D Phase Contrast MR: Validation and Evaluation of Hypertrophy in Liver Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Ability of the 4D PC MRA to measure portal venous flow findings compared to reference standards of catheter-based flow quantification
研究概览
简要总结
The investigators hypothesize that 4Dimensional Phase Contrast Magnetic Resonance Angiography (4D PC MRA) evaluation of portal venous flow predicts underlying liver function and hypertrophic potential in patients with liver cancer presenting for portal vein embolization (PVE). 4D PC MRA may provide a non-invasive measure of liver function that could help determine which patients could safely and successfully undergo PVE and subsequent resection of tumor. By comparing 4D PC MRA results with invasive catheter measurements the investigators will validate the flow findings. Further regression/correlation analysis with functional measures of the liver (HIDA scans), volumetrics, Doppler flow analysis, histology, and outcomes will help the investigators to determine the ability of 4D PC MRA to predict functional status and hypertrophic potential of the liver prior to PVE and hepatectomy allowing for better patient selection and reduced morbidity/mortality.
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
- •Diagnosis of malignant liver tumor
- •Clinically referred for portal vein embolization
- •At least 18 years of age
- •Willing and able to provide informed consent
排除标准
- •Documented or reported contrast allergy
- •Unable to receive or tolerate MRI scan after evaluation of MRI screening form
- •GFR (glomerular filtration rate) < 30 on labs drawn within 6 weeks of imaging.
结局指标
主要结局
Ability of the 4D PC MRA to measure portal venous flow findings compared to reference standards of catheter-based flow quantification
时间窗: Up to 6-8 weeks post PVE
-Data from the 4D PC MRA will be compared with the reference standards of the catheter-based flow quantification to validate venous flow findings
Ability of the 4D PC MRA to measure flow velocities as compared to reference standards of the Doppler Flow Analysis
时间窗: Up to 6-8 weeks post PVE
-Data from the 4D PC MRA will be compared with the reference standards of the Doppler Flow Analysis to measure flow velocities
Ability of the 4D PC MRA to measure liver function
时间窗: Up to 6-8 weeks post PVE
-4D PC MRA results will be compared with invasive catheter measurements to validate the portal venous flow findings. Regression/correlation analysis will be used to analyze association between 4D PC MRA and liver function. Residuals will be tested for normality with the Shapiro-Wilk W test, and if residuals are non-normally distributed, the Spearman's rank correlation coefficient will be used
Ability of the 4D PC MRA to measure hypertrophic potential (liver function is preserved)
时间窗: Up to 6-8 weeks post PVE
-Data from the 4D PC MRA will be compared with the reference standards of the HIDA scan and biopsy specimens.
Ability of the 4D PC MRA to measure flow direction of flow as compared to reference standards of the Doppler Flow Analysis
时间窗: Up to 6-8 weeks post PVE
-Data from the 4D PC MRA will be compared with the reference standards of the Doppler Flow Analysis to measure direction of flow
次要结局
未报告次要终点