Clinical trial NCT02299934: 3T MR Angiography of the Hepatic Vasculature
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Blood Supply
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Liver Blood Supply Diameters
timeFrame: Day 1
measure: The Visibility of the Variations of the Liver Blood Supply
timeFrame: Day 1
measure: Detection Rates of the Variations of the Liver Blood Supply
timeFrame: Day 1
measure: The Percentage of Examinations With the Presence of Significant Artifacts Interfering Interpretation.
timeFrame: Day 1
measure: How Badly the Artifacts Prevented Evaluation by the Reader.
timeFrame: Day 1
measure: The Relative Signal Intensity of the Liver Blood Supply
timeFrame: Day 1
measure: Documentation of Acquisition Time
timeFrame: Day 1
Secondary outcomes:
measure: The Percentage of Examinations That Caused Adverse Events
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Samuel Chang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.