3T MR Angiography of the Hepatic Vasculature

3T MR Angiography of the Hepatic Vasculature: A Pilot Comparison Study of New Noncontrast Techniques to Post-contrast Technique and CT Angiography in Liver Donors.

This study plans to learn more about the two Magnetic Resonance Angiography (MRA) techniques.

Study Overview

• Status: Terminated
• Conditions: Liver Blood Supply
• Intervention / Treatment: Diagnostic test: Magnetic Resonance Imaging (MRI); Diagnostic test: Compurtized Tomgraphy (CT)

Detailed Description

This study will use two Magnetic Resonance Angiography (MRA) techniques that will look at participants liver veins and arteries without giving a coloring matter (contrast) before taking the images. Investigators propose to evaluate the usefulness of these two new techniques, which do not involve exposing participants to radiation or contrast.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects that fulfill the criteria for living liver donation and are evaluated for the procedure with CT and MR.

Exclusion Criteria:

• Unable to give informed consent
• Unable to comply with breathing or other imaging related instructions resulting in inability to obtain diagnostic quality MRI studies

• Not suitable to undergo MRI with a gadolinium-based contrast agent because of:

  • Claustrophobia, unless patient agrees to sedation measures per institutional standard practice during MR imaging
  • Presence of metallic objects or implanted medical devices in body per institutional safety standards
  • Weight greater than that allowable by the MR table
  • Renal failure, as determined by estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 by the Modification of Diet in Renal Disease (MDRD) model based on a serum creatinine level obtained within 28 days prior to enrollment
  • Known allergy-like reaction to contrast media (gadolinium) or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR), and unwillingness to undergo pre-treatment as defined by the institution's policy and/or ACR guidance
  • Pregnancy (if a female is of childbearing potential --defined as a premenopausal female capable of becoming pregnant --a pregnancy test should be done)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Subjects who fulfill the criteria for living liver donation; Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).	Diagnostic test: Magnetic Resonance Imaging (MRI); MRI sequences for visualisation of the blood supply of liver without contrast agent.; Diagnostic test: Compurtized Tomgraphy (CT); CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Liver Blood Supply Diameters	Day 1
The Visibility of the Variations of the Liver Blood Supply	Day 1
Detection Rates of the Variations of the Liver Blood Supply	Day 1
The Percentage of Examinations With the Presence of Significant Artifacts Interfering Interpretation.	Day 1
How Badly the Artifacts Prevented Evaluation by the Reader.	Day 1
The Relative Signal Intensity of the Liver Blood Supply	Day 1
Documentation of Acquisition Time	Day 1

Secondary Outcome Measures

Outcome Measure	Time Frame
The Percentage of Examinations That Caused Adverse Events	Day 1

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Samuel Chang, University of Colorado, Denver

Publications and helpful links

General Publications

• Puippe GD, Alkadhi H, Hunziker R, Nanz D, Pfammatter T, Baumueller S. Performance of unenhanced respiratory-gated 3D SSFP MRA to depict hepatic and visceral artery anatomy and variants. Eur J Radiol. 2012 Aug;81(8):e823-9. doi: 10.1016/j.ejrad.2012.02.016. Epub 2012 May 10.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 14, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 14-1213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will only be shared to research personnel.