4D Phase Contrast MR: Hypertrophy in Liver Cancer

The Washington University

Status: Terminated

Conditions: Liver Cancer; Cancer of the Liver

Treatments: Device: 4Dimensional Phase Contrast Magnetic Resonance Angiography; Procedure: Portal vein embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT02618447

201406079

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Arm 1: 4D phase contrast MR scan

Experimental group

Description:

* 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.

Treatment:

Procedure: Portal vein embolization

Device: 4Dimensional Phase Contrast Magnetic Resonance Angiography