Liver Blood Supply
Conditions
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.
Interventions
DIAGNOSTIC_TESTMagnetic Resonance Imaging (MRI)
MRI sequences for visualisation of the blood supply of liver without contrast agent.
DIAGNOSTIC_TESTCompurtized Tomgraphy (CT)
CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.
Sponsors
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Documentation of Acquisition Time | Day 1 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| The Percentage of Examinations That Caused Adverse Events | Day 1 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
Magnetic Resonance Imaging (MRI): MRI sequences for visualisation of the blood supply of liver without contrast agent.
Compurtized Tomgraphy (CT): CT including CT Angiography (CTA) for the evaluation of hepatic vasculature. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Termination of study | 13 |
Baseline characteristics
| Characteristic | Subjects Who Fulfill the Criteria for Living Liver Donation | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 13 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 13 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Detection Rates of the Variations of the Liver Blood Supply
Time frame: Day 1
Population: Study was terminated prior to collecting any outcome measure data.
Primary
Documentation of Acquisition Time
Time frame: Day 1
Population: Study was terminated prior to collecting any outcome measure data.
Primary
How Badly the Artifacts Prevented Evaluation by the Reader.
Time frame: Day 1
Population: Study was terminated prior to collecting any outcome measure data.
Primary
Liver Blood Supply Diameters
Time frame: Day 1
Population: Study was terminated prior to collecting any outcome measure data.
Primary
The Percentage of Examinations With the Presence of Significant Artifacts Interfering Interpretation.
Time frame: Day 1
Population: Study was terminated prior to collecting any outcome measure data.
Primary
The Relative Signal Intensity of the Liver Blood Supply
Time frame: Day 1
Population: Study was terminated prior to collecting any outcome measure data.
Primary
The Visibility of the Variations of the Liver Blood Supply
Time frame: Day 1
Population: Study was terminated prior to collecting any outcome measure data.
Secondary
The Percentage of Examinations That Caused Adverse Events
Time frame: Day 1
Population: Study was terminated prior to collecting any outcome measure data.