4D Phase Contrast MR: Hypertrophy in Liver Cancer

Not Applicable

Terminated

• Conditions: Liver Cancer; Cancer of the Liver
• Interventions: Device: 4Dimensional Phase Contrast Magnetic Resonance Angiography; Procedure: Portal vein embolization

• Registration Number: NCT02618447
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-05
• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-12-01
• Primary Completion: 2016-02-04
• Study Completion: 2016-02-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1: 4D phase contrast MR scan	Portal vein embolization	* 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.
Arm 1: 4D phase contrast MR scan	4Dimensional Phase Contrast Magnetic Resonance Angiography	* 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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States