3T MR Angiography of the Hepatic Vasculature

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

Detailed Description
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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.

Official Title
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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.

Conditions
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Liver Blood Supply

Intervention / Treatment
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* Diagnostic Test: Magnetic Resonance Imaging (MRI)
* Diagnostic Test: Compurtized Tomgraphy (CT)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subjects who fulfill the criteria for living liver donation<br>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)<br>* MRI sequences for visualisation of the blood supply of liver without contrast agent.<br>Diagnostic Test: Compurtized Tomgraphy (CT)<br>* CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.<br>|

What is the study measuring?
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Primary Outcome Measures

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