3T MR Angiography of the Hepatic Vasculature

NCT ID: NCT02299934

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-12-31

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.

Conditions

Liver Blood Supply

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

Magnetic Resonance Imaging (MRI)

Intervention Type: DIAGNOSTIC_TEST

MRI sequences for visualisation of the blood supply of liver without contrast agent.

Compurtized Tomgraphy (CT)

Intervention Type: DIAGNOSTIC_TEST

CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.

Interventions

Magnetic Resonance Imaging (MRI)

MRI sequences for visualisation of the blood supply of liver without contrast agent.

Intervention Type: DIAGNOSTIC_TEST

Compurtized Tomgraphy (CT)

CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.

Intervention Type: DIAGNOSTIC_TEST

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Chang

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

References

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.

Reference Type: BACKGROUND

PMID: 22578837 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14-1213

Identifier Type: -

Identifier Source: org_study_id