Liver DiseaseNCT02684526
Is Eovist Suitable for Arterial-Phase MR Imaging of Liver
A study testing Eovist Contrast and Non Eovist Contrast in people with Liver Disease, run by University of Michigan at 1 site in United States.
Trial summary
To examine the quality of liver images produced when the contrast agent Eovist is used during MRI. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Liver Disease
- What is being tested?
- Eovist Contrast and Non Eovist Contrast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Oct 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You have had a scheduled MRI(magnetic resonance imaging) scan using the contrast agent EOVIST.
- Male and females 21 years of age or older.
Who cannot join
- Does not have a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants).
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
To examine the quality of liver images produced when the contrast agent Eovist is used during MRI.
Read the detailed description
Researchers will review data from the Eovist MRI and compare the scan with previous MRI exams the patient had with the same or other contrast agents.
To determine the efficacy of Eovist contrast agent in producing MRI images of the liver. We will monitor patients for any unusual symptoms (adverse events) when the contrast is given.
Patients are asked to hold their breath during an MRI scan. Eovist may interfere with the "breath hold" which could result in more breathing artifacts (based on a qualitative scale) on arterial images when the patients are given Eovist vs. other contrast agents.
- Conditions
- Liver Disease
- Being tested
- Eovist Contrast, Non Eovist Contrast
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eovist ContrastProcedure or surgery
Subjects will undergo an MRI (magnetic resonance imaging) scan using the Eovist contrast agent. This MRI scan takes approximately 45minutes to 1 hour to complete.
Non Eovist ContrastProcedure or surgery
Subjects will undergo an MRI (magnetic resonance imaging) scan using a contrast agent other than Eovist. This MRI scan takes approximately 45minutes to 1 hour to complete.
| Study group | Role | What they receive |
|---|---|---|
| Eovist Contrast agent | Active comparator | To determine if Eovist contrast agent induces a transient abnormal sensation at first pass, which prevents patients from holding their breath at end of arterial phase liver MRI scans. Receives: Procedure: Eovist Contrast |
| Non Eovist Contrast agents | Active comparator | To determine if using non-Eovist contrast agents produce the same abnormal sensation at first pass, which prevents patients from holding their breath at end of arterial phase liver MRI scans. Determine if this event is exclusive to Eovist contrast. Receives: Procedure: Non Eovist Contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scanning artifacts on MRI with Eovist
To qualitatively assess and score MRI images during unenhanced and contrast-enhanced motion-sensitive sequences for breathing artifacts when Eovist contrast is used versus other contrast agents. Eovist enhanced MRI scans will be compared to previous MRI scans performed with other contrast agents on the same patient that included breath holding sequences. Breathing artifacts on both scans will be evaluated using a respiratory motion score between 1 and 5.
Measured: 5 years
Secondary outcomes (1)
Adverse events (including dyspnea)
Number of patients complaining of adverse events after MRI contrast administration.
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startDec 2011
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hero Hussain, MD, University of Michigan
- Investigators
- Hero Hussain, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684526
- Sponsor's protocol ID
- HUM00038856
- Status last verified
- Oct 2016
- First submitted
- 14 Mar 2013
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Eovist Suitable for Arterial-Phase MR Imaging of Liver
- ClinicalTrials.gov ID
- NCT02684526
- Acronym / sponsor ID
- HUM00038856
- Conditions
- Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Feb 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.
To examine the quality of liver images produced when the contrast agent Eovist is used during MRI.
Detailed description
Researchers will review data from the Eovist MRI and compare the scan with previous MRI exams the patient had with the same or other contrast agents.
To determine the efficacy of Eovist contrast agent in producing MRI images of the liver. We will monitor patients for any unusual symptoms (adverse events) when the contrast is given.
Patients are asked to hold their breath during an MRI scan. Eovist may interfere with the "breath hold" which could result in more breathing artifacts (based on a qualitative scale) on arterial images when the patients are given Eovist vs. other contrast agents.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eovist Contrast agent | Active comparator | Procedure: Eovist ContrastTo determine if Eovist contrast agent induces a transient abnormal sensation at first pass, which prevents patients from holding their breath at end of arterial phase liver MRI scans. |
| Non Eovist Contrast agents | Active comparator | Procedure: Non Eovist ContrastTo determine if using non-Eovist contrast agents produce the same abnormal sensation at first pass, which prevents patients from holding their breath at end of arterial phase liver MRI scans. Determine if this event is exclusive to Eovist contrast. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- You have had a scheduled MRI(magnetic resonance imaging) scan using the contrast agent EOVIST.
- Male and females 21 years of age or older.
Key exclusion criteria (2 listed)
- Does not have a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants).
- Pregnancy
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 |
|---|---|---|
| Eovist ContrastSubjects will undergo an MRI (magnetic resonance imaging) scan using the Eovist contrast agent. This MRI scan takes approximately 45minutes to 1 hour to complete. | Procedure or surgery | Eovist Contrast agent |
| Non Eovist ContrastSubjects will undergo an MRI (magnetic resonance imaging) scan using a contrast agent other than Eovist. This MRI scan takes approximately 45minutes to 1 hour to complete. | Procedure or surgery | Non Eovist Contrast agents |
Primary outcome
Scanning artifacts on MRI with Eovist
Time frame: 5 years
To qualitatively assess and score MRI images during unenhanced and contrast-enhanced motion-sensitive sequences for breathing artifacts when Eovist contrast is used versus other contrast agents. Eovist enhanced MRI scans will be compared to previous MRI scans performed with other contrast agents on the same patient that included breath holding sequences. Breathing artifacts on both scans will be evaluated using a respiratory motion score between 1 and 5.
1 secondary outcome
Adverse events (including dyspnea)
Time frame: 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- 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.
Hero Hussain, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eovist Contrast and Non Eovist Contrast in people with Liver Disease, run by University of Michigan at 1 site in United States.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Scanning artifacts on MRI with Eovist (time frame: 5 years). 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 16 Dec 2016.