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Trial record 44 of 44 for:    Gadoxetate

4D Phase Contrast MR: Hypertrophy in Liver Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 18, 2015
First Posted Date  ICMJE December 1, 2015
Last Update Posted Date April 7, 2017
Actual Study Start Date  ICMJE August 5, 2014
Actual Primary Completion Date February 4, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
  • 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
  • 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
  • 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
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02618447 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 4D Phase Contrast MR: Hypertrophy in Liver Cancer
Official Title  ICMJE 4D Phase Contrast MR: Validation and Evaluation of Hypertrophy in Liver Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Liver Cancer
  • Cancer of the Liver
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Device: 4Dimensional Phase Contrast Magnetic Resonance Angiography
  • Procedure: Portal vein embolization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 5, 2017)
10
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2015)
20
Actual Study Completion Date  ICMJE February 4, 2016
Actual Primary Completion Date February 4, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02618447
Other Study ID Numbers  ICMJE 201406079
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nael E Saad, M.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP