4D Phase Contrast MR: Hypertrophy in Liver Cancer

Study Overview
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Brief Summary
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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.

Official Title
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4D Phase Contrast MR: Validation and Evaluation of Hypertrophy in Liver Cancer

Conditions
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Liver Cancer, Cancer of the Liver

Intervention / Treatment
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* Device: 4Dimensional Phase Contrast Magnetic Resonance Angiography
* Procedure: Portal vein embolization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: 4D phase contrast MR scan<br>Each patient will undergo a total of 3 MRI/MRA scans (lasting 30-60 minutes): Scan 1: Baseline (pre-portal vein embolization (PRE)) Scan 2: Early after PVE (within 48 hours) Scan 3: Late after PVE (at 3-8 weeks). Scans 1 and 3: routine liver MR sequences with/without contrast (Gadoxetic acid, Eovist) and 4D phase contrast of the portal venous system. The 4D phase contrast sequence will be repeated twice at each time point, adding about 15-30 minutes to each scan. Scan 2: 4D phase contrast sequences and imaging for localization. | Device: 4Dimensional Phase Contrast Magnetic Resonance Angiography<br>* 4D PC MRA is a new non-contrast MRA technique that can measure flow of blood within vessels of interest over time.<br>* Other names: 4D PC MRA;Procedure: Portal vein embolization<br> <br> * Other names: PRE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of the 4D PC MRA to measure portal venous flow findings compared to reference standards of catheter-based flow quantification | -Data from the 4D PC MRA will be compared with the reference standards of the catheter-based flow quantification to validate venous flow findings | Up to 6-8 weeks post PVE | 
| Ability of the 4D PC MRA to measure flow velocities as compared to reference standards of the Doppler Flow Analysis | -Data from the 4D PC MRA will be compared with the reference standards of the Doppler Flow Analysis to measure flow velocities | Up to 6-8 weeks post PVE | 
| Ability of the 4D PC MRA to measure liver function | -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 | Up to 6-8 weeks post PVE | 
| Ability of the 4D PC MRA to measure hypertrophic potential (liver function is preserved) | -Data from the 4D PC MRA will be compared with the reference standards of the HIDA scan and biopsy specimens. | Up to 6-8 weeks post PVE | 
| Ability of the 4D PC MRA to measure flow direction of flow as compared to reference standards of the Doppler Flow Analysis | -Data from the 4D PC MRA will be compared with the reference standards of the Doppler Flow Analysis to measure direction of flow | Up to 6-8 weeks post PVE |