4D Phase Contrast MR: Hypertrophy in Liver Cancer
Primary Purpose
Liver Cancer, Cancer of the Liver
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
4Dimensional Phase Contrast Magnetic Resonance Angiography
Portal vein embolization
Sponsored by
About this trial
This is an interventional device feasibility trial for Liver Cancer
Eligibility Criteria
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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1: 4D phase contrast MR scan
Arm 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.
Outcomes
Primary Outcome Measures
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
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
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
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02618447
First Posted
November 18, 2015
Last Updated
April 5, 2017
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02618447
Brief Title
4D Phase Contrast MR: Hypertrophy in Liver Cancer
Official Title
4D Phase Contrast MR: Validation and Evaluation of Hypertrophy in Liver Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Insufficient funding
Study Start Date
August 5, 2014 (Actual)
Primary Completion Date
February 4, 2016 (Actual)
Study Completion Date
February 4, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Cancer of the Liver
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: 4D phase contrast MR scan
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
4Dimensional Phase Contrast Magnetic Resonance Angiography
Other Intervention Name(s)
4D PC MRA
Intervention Description
4D PC MRA is a new non-contrast MRA technique that can measure flow of blood within vessels of interest over time.
Intervention Type
Procedure
Intervention Name(s)
Portal vein embolization
Other Intervention Name(s)
PRE
Primary Outcome Measure Information:
Title
Ability of the 4D PC MRA to measure portal venous flow findings compared to reference standards of catheter-based flow quantification
Description
-Data from the 4D PC MRA will be compared with the reference standards of the catheter-based flow quantification to validate venous flow findings
Time Frame
Up to 6-8 weeks post PVE
Title
Ability of the 4D PC MRA to measure flow velocities as compared to reference standards of the Doppler Flow Analysis
Description
-Data from the 4D PC MRA will be compared with the reference standards of the Doppler Flow Analysis to measure flow velocities
Time Frame
Up to 6-8 weeks post PVE
Title
Ability of the 4D PC MRA to measure liver function
Description
-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
Time Frame
Up to 6-8 weeks post PVE
Title
Ability of the 4D PC MRA to measure hypertrophic potential (liver function is preserved)
Description
-Data from the 4D PC MRA will be compared with the reference standards of the HIDA scan and biopsy specimens.
Time Frame
Up to 6-8 weeks post PVE
Title
Ability of the 4D PC MRA to measure flow direction of flow as compared to reference standards of the Doppler Flow Analysis
Description
-Data from the 4D PC MRA will be compared with the reference standards of the Doppler Flow Analysis to measure direction of flow
Time Frame
Up to 6-8 weeks post PVE
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nael E Saad, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
4D Phase Contrast MR: Hypertrophy in Liver Cancer
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