3T MR Angiography of the Hepatic Vasculature

Not Applicable

Terminated

• Conditions: Liver Blood Supply
• Interventions: Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: Compurtized Tomgraphy (CT)

• Registration Number: NCT02299934
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Primary Completion: 2017-09
• Study Completion: 2017-12
• Results First Submitted: 2019-02-21
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-15
• Last Update Submitted: 2019-04-15
• Results First Posted: 2019-05-07
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects who fulfill the criteria for living liver donation	Magnetic Resonance Imaging (MRI)	Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).
Subjects who fulfill the criteria for living liver donation	Compurtized Tomgraphy (CT)	Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI).

Primary Outcome Measures

Name	Time	Method
Detection Rates of the Variations of the Liver Blood Supply	Day 1
The Relative Signal Intensity of the Liver Blood Supply	Day 1
Documentation of Acquisition Time	Day 1
Liver Blood Supply Diameters	Day 1
The Visibility 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

Secondary Outcome Measures

Name	Time	Method
The Percentage of Examinations That Caused Adverse Events	Day 1