4D Phase Contrast MR: Hypertrophy in Liver Cancer

NCT02618447 | Terminated DMC FDA Device

• 1 other identifier: 201406079
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Cancer of the Liver

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Arm 1: 4D phase contrast MR scan

EXPERIMENTAL

* 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; Procedure: Portal vein embolization

Interventions

4Dimensional Phase Contrast Magnetic Resonance Angiography DEVICE

4D PC MRA is a new non-contrast MRA technique that can measure flow of blood within vessels of interest over time.

Also known as: 4D PC MRA

Arm 1: 4D phase contrast MR scan

Portal vein embolization PROCEDURE

Also known as: PRE

Arm 1: 4D phase contrast MR scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of malignant liver tumor
• Clinically referred for portal vein embolization
• At least 18 years of age
• Willing and able to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Nael E Saad, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: December 1, 2015
• Study Start: August 5, 2014
• Primary Completion: February 4, 2016
• Study Completion: February 4, 2016
• Last Updated: April 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)