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4D Phase Contrast MR: Hypertrophy in Liver Cancer

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ClinicalTrials.gov Identifier: NCT02618447
Recruitment Status : Terminated (Insufficient funding)
First Posted : December 1, 2015
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Liver Cancer Cancer of the Liver Device: 4Dimensional Phase Contrast Magnetic Resonance Angiography Procedure: Portal vein embolization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: 4D Phase Contrast MR: Validation and Evaluation of Hypertrophy in Liver Cancer
Actual Study Start Date : August 5, 2014
Actual Primary Completion Date : February 4, 2016
Actual Study Completion Date : February 4, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

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 Name: 4D PC MRA

Procedure: Portal vein embolization
Other Name: PRE




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618447


Locations
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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Nael E Saad, M.D. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02618447     History of Changes
Other Study ID Numbers: 201406079
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Liver Neoplasms
Hypertrophy
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Pathological Conditions, Anatomical