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lack of support
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This study plans to learn more about the two Magnetic Resonance Angiography (MRA) techniques.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects who fulfill the criteria for living liver donation | Other | Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Diagnostic Test | MRI sequences for visualisation of the blood supply of liver without contrast agent. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Examinations That Caused Adverse Events | Day 1 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Chang | University of Colorado, Denver | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22578837 | Background | 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. |
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Participant data will only be shared to research personnel.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
13 patients were consented and began the preliminary examination. 11 completed the preliminary examination after consenting.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Liver Blood Supply Diameters | Study was terminated prior to collecting any outcome measure data. | Posted | Day 1 |
|
|
Duration of study activity (approximately 2 years)
This study was terminated early due to lack of enrollment. No adverse events data was reported prior to early termination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Study was terminated prior to collecting any outcome measure data or performing any image analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Samuel Chang | University of Colorado, Denver | 720-848-1875 | SAMUEL.CHANG@UCDENVER.EDU |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2014 | Apr 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Compurtized Tomgraphy (CT) | Diagnostic Test | CT including CT Angiography (CTA) for the evaluation of hepatic vasculature. |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | The Visibility of the Variations of the Liver Blood Supply | Study was terminated prior to collecting any outcome measure data. | Posted | Day 1 |
|
|
| Primary | Detection Rates of the Variations of the Liver Blood Supply | Study was terminated prior to collecting any outcome measure data. | Posted | Day 1 |
|
|
| Primary | The Percentage of Examinations With the Presence of Significant Artifacts Interfering Interpretation. | Study was terminated prior to collecting any outcome measure data. | Posted | Day 1 |
|
|
| Primary | How Badly the Artifacts Prevented Evaluation by the Reader. | Study was terminated prior to collecting any outcome measure data. | Posted | Day 1 |
|
|
| Primary | The Relative Signal Intensity of the Liver Blood Supply | Study was terminated prior to collecting any outcome measure data. | Posted | Day 1 |
|
|
| Primary | Documentation of Acquisition Time | Study was terminated prior to collecting any outcome measure data. | Posted | Day 1 |
|
|
| Secondary | The Percentage of Examinations That Caused Adverse Events | Study was terminated prior to collecting any outcome measure data. | Posted | Day 1 |
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
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