Liver Blood SupplyNCT02299934
3T MR Angiography of the Hepatic Vasculature
A study testing Magnetic Resonance Imaging (MRI) and Compurtized Tomgraphy (CT) in people with Liver Blood Supply, run by University of Colorado, Denver.
Trial summary
This study plans to learn more about the two Magnetic Resonance Angiography (MRA) techniques. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Blood Supply
- What is being tested?
- Magnetic Resonance Imaging (MRI) and Compurtized Tomgraphy (CT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects that fulfill the criteria for living liver donation and are evaluated for the procedure with CT and MR.
Who cannot join
- 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
Show all 9Show fewer
- 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)
About this study
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.
This study plans to learn more about the two Magnetic Resonance Angiography (MRA) techniques.
Read the 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
- Being tested
- Magnetic Resonance Imaging (MRI), Compurtized Tomgraphy (CT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Diagnostic test
MRI sequences for visualisation of the blood supply of liver without contrast agent.
Compurtized Tomgraphy (CT)Diagnostic test
CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI); Diagnostic Test: Compurtized Tomgraphy (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Blood Supply Diameters
Measured: Day 1
The Visibility of the Variations of the Liver Blood Supply
Measured: Day 1
Detection Rates of the Variations of the Liver Blood Supply
Measured: Day 1
The Percentage of Examinations With the Presence of Significant Artifacts Interfering Interpretation.
Measured: Day 1
How Badly the Artifacts Prevented Evaluation by the Reader.
Measured: Day 1
The Relative Signal Intensity of the Liver Blood Supply
Measured: Day 1
Documentation of Acquisition Time
Measured: Day 1
Secondary outcomes (1)
The Percentage of Examinations That Caused Adverse Events
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2017
- Study completionDec 2017
Why it stopped: lack of support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Blood SupplyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Chang, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299934
- Sponsor's protocol ID
- 14-1213
- Status last verified
- Apr 2019
- First submitted
- 14 Nov 2014
- Last updated
- 7 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Participant data will only be shared to research personnel.
Publications
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.
PubMed 22578837
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02299934
- Acronym / sponsor ID
- 14-1213
- Conditions
- Liver Blood Supply
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of support
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Posted 7 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who fulfill the criteria for living liver donation | Other | Diagnostic Test: Magnetic Resonance Imaging (MRI), Diagnostic Test: Compurtized Tomgraphy (CT)Subjects who fulfill the criteria for living liver donation and are evaluated for the procedure with Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects that fulfill the criteria for living liver donation and are evaluated for the procedure with CT and MR.
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)MRI sequences for visualisation of the blood supply of liver without contrast agent. | Diagnostic test | Subjects who fulfill the criteria for living liver donation |
| Compurtized Tomgraphy (CT)CT including CT Angiography (CTA) for the evaluation of hepatic vasculature. | Diagnostic test | Subjects who fulfill the criteria for living liver donation |
Primary outcome
Liver Blood Supply Diameters
Time frame: Day 1
The Visibility of the Variations of the Liver Blood Supply
Time frame: Day 1
Detection Rates of the Variations of the Liver Blood Supply
Time frame: Day 1
The Percentage of Examinations With the Presence of Significant Artifacts Interfering Interpretation.
Time frame: Day 1
How Badly the Artifacts Prevented Evaluation by the Reader.
Time frame: Day 1
The Relative Signal Intensity of the Liver Blood Supply
Time frame: Day 1
Documentation of Acquisition Time
Time frame: Day 1
1 secondary outcome
The Percentage of Examinations That Caused Adverse Events
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22578837Puippe 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.
- Individual participant dataSharing planned: No. Participant data will only be shared to research personnel.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Chang principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI) and Compurtized Tomgraphy (CT) in people with Liver Blood Supply, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Blood Supply Diameters (time frame: Day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02299934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.