Fatty LiverNCT02873507
Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging
A study testing MRI of donor liver prior to transplant in people with Fatty Liver and Steatosis of Liver, run by Vanderbilt University Medical Center.
Trial summary
A pilot prospective cohort study assessing the clinical utility of MRI evaluation of graft steatosis prior to transplantation will be conducted. An MRI of the donor liver within the transport cooler will be obtained on its way to the operating room. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Fatty Liver, Steatosis of Liver
- What is being tested?
- MRI of donor liver prior to transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are scheduled to orthoptic liver transplant
Who cannot join
- Patient's who do not agree to sign consent
About this study
Official title: Pilot Study for the Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging
A pilot prospective cohort study assessing the clinical utility of MRI evaluation of graft steatosis prior to transplantation will be conducted. An MRI of the donor liver within the transport cooler will be obtained on its way to the operating room.
Read the detailed description
The images from MRI will be analyzed to obtain information of fat content in all eight segments of the liver. Demographic, intra-operative, and post-operative patient data will be collected for each imaged graft.
- Conditions
- Fatty Liver, Steatosis of Liver
- Being tested
- MRI of donor liver prior to transplant
- Keywords
- transplantation, liver
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI of donor liver prior to transplantOther
MRI of the on ice donor liver within the transport cooler on its way to the operating room
| Study group | Role | What they receive |
|---|---|---|
| MRI of donor liver | Experimental | MRI evaluation of graft steatosis in donor liver prior to transplantation Receives: Other: MRI of donor liver prior to transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Hepatic Steatosis of a Donor Liver Prior to Transplantation
Amount of fat measured in the donor liver prior to transplant surgery using MRI scan
Measured: Measured immediately prior to liver transplant
Secondary outcomes (3)
Comparison of steatosis percentages provided by biopsy to MRI results
Measured: Baseline
Length of hospitalization of transplant recipient
Measured: Days to hospital discharge, approximately 2 weeks
Mortality of liver transplant recipient at 1 year post transplantation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startMay 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bret Alvis, Vanderbilt University Medical Center
- Investigators
- Bret D Alvis, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873507
- Sponsor's protocol ID
- 160152
- Status last verified
- Jan 2018
- First submitted
- 4 Aug 2016
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Prediction of Donor Liver Adipose Content by Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02873507
- Acronym / sponsor ID
- 160152
- Conditions
- Fatty Liver, Steatosis of Liver
- Keywords
- transplantation, liver
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot prospective cohort study assessing the clinical utility of MRI evaluation of graft steatosis prior to transplantation will be conducted. An MRI of the donor liver within the transport cooler will be obtained on its way to the operating room.
Detailed description
The images from MRI will be analyzed to obtain information of fat content in all eight segments of the liver. Demographic, intra-operative, and post-operative patient data will be collected for each imaged graft.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI of donor liver | Experimental | Other: MRI of donor liver prior to transplantMRI evaluation of graft steatosis in donor liver prior to transplantation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are scheduled to orthoptic liver transplant
Key exclusion criteria (1 listed)
- Patient's who do not agree to sign consent
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 |
|---|---|---|
| MRI of donor liver prior to transplantMRI of the on ice donor liver within the transport cooler on its way to the operating room | Other | MRI of donor liver |
Primary outcome
Percent Hepatic Steatosis of a Donor Liver Prior to Transplantation
Time frame: Measured immediately prior to liver transplant
Amount of fat measured in the donor liver prior to transplant surgery using MRI scan
3 secondary outcomes
Comparison of steatosis percentages provided by biopsy to MRI results
Time frame: Baseline
Length of hospitalization of transplant recipient
Time frame: Days to hospital discharge, approximately 2 weeks
Mortality of liver transplant recipient at 1 year post transplantation
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Bret D Alvis, M.D. principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing MRI of donor liver prior to transplant in people with Fatty Liver and Steatosis of Liver, run by Vanderbilt University Medical Center.
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 1 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: withdrawn, as of the sponsor's last update on 5 Feb 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percent Hepatic Steatosis of a Donor Liver Prior to Transplantation (time frame: Measured immediately prior to liver transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2018.