Cancer of the Liver, Liver Cancer
Conditions
Brief summary
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.
Interventions
DEVICE4Dimensional Phase Contrast Magnetic Resonance Angiography
4D PC MRA is a new non-contrast MRA technique that can measure flow of blood within vessels of interest over time.
PROCEDUREPortal vein embolization
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of malignant liver tumor * Clinically referred for portal vein embolization * At least 18 years of age * Willing and able to provide informed consent
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability of the 4D PC MRA to measure portal venous flow findings compared to reference standards of catheter-based flow quantification | 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 | 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 | 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) | 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 | 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 |
Countries
United States
Outcome results
None listed