4D Phase Contrast MR: Hypertrophy in Liver Cancer

April 5, 2017 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: 4D phase contrast MR scan

  • 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
4D PC MRA is a new non-contrast MRA technique that can measure flow of blood within vessels of interest over time.
Other Names:
  • 4D PC MRA
Procedure: Portal vein embolization
Other Names:
  • PRE

What is the study measuring?

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
Time Frame: 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
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
Time Frame: 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
Up to 6-8 weeks post PVE
Ability of the 4D PC MRA to measure liver function
Time Frame: 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
Up to 6-8 weeks post PVE
Ability of the 4D PC MRA to measure hypertrophic potential (liver function is preserved)
Time Frame: 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.
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
Time Frame: 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
Up to 6-8 weeks post PVE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Nael E Saad, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2014

Primary Completion (Actual)

February 4, 2016

Study Completion (Actual)

February 4, 2016

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201406079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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