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Magnetic Resonance ImagingPhase 3NCT02084628

Magnetic Resonance Imaging of the Liver in Children 0-2 Months of Age With an Intravenous Injection of Eovist/Primovist Which is a Contrast Agent

A Phase 3 study testing Gadoxetate disodium (Eovist/Primovist, BAY86-4873) in people with Magnetic Resonance Imaging, run by Bayer at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label, multi-center study involving babies 0-2 months of age who have liver problems (pathology) and need to have their liver and possibly, the bile ducts imaged using magnetic resonance imaging and injection of a contrast agent (dye). This agent is called Eovist. Read more about this study

Who is it for?
Ages Up to 2 months
Conditions the study is for
Magnetic Resonance Imaging
What is being tested?
Gadoxetate disodium (Eovist/Primovist, BAY86-4873)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
9 sitesUnited States
Study dates
Feb 2015to Aug 2015
Phase
Phase 3
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 Up to 2 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 0-2 months (must be gestational age 37 to 41 weeks)
  • Scheduled to undergo routine contrast-enhanced liver MRI
  • Able to comly with the study procedures

Who cannot join

  • Scheduled for any intervention (except lumbar puncture and bone marrow aspiration) during the study period
  • If receiving chemotherapy, may have a change in treatment during the study period
  • Contraindication for MRI
  • Renal insufficiency (estimated glomerular filtration rate < 80% of age-adjusted normal mean value using the Schwartz formula)
  • Acute renal failure
  • Clinically relevant abnormal laboratory parameter, ie, greater than 3 times the upper limit of the normal range, in particular, liver enzymes and renal function. (Note: if elevations in liver enzyme levels are consistent with the underlying hepatobiliary disease, then the subject may be enrolled.)

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Study site

    Brooklyn, New York, 11219

  • Study site

    Cincinnati, Ohio, 45229

  • Study site

    Los Angeles, California, 90027-6089

  • Study site

    Madison, Wisconsin, 53792

  • Study site

    New York, New York, 10032

  • Study site

    Palo Alto, California, 94304

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Seattle, Washington, 98105

  • Study site

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: Open-label, Multi-center Study to Evaluate the Safety, Efficacy, and Plasma Gadolinium Concentrations After an Intravenous Injection of 0.1 mL/kg Body Weight Eovist/Primovist for Enhanced Magnetic Resonance Imaging (MRI) of the Liver in Children 0 to 2 Months of Age

This is an open-label, multi-center study involving babies 0-2 months of age who have liver problems (pathology) and need to have their liver and possibly, the bile ducts imaged using magnetic resonance imaging and injection of a contrast agent (dye). This agent is called Eovist. It has been marketed since 2004 and used in many countries all over the world.

The baby will have blood tests before and after the imaging is done to make sure that there are no unexpected findings before and after the imaging. Also 3 blood samples up to 8 hours after the injection will be obtained in order to measure how much of the dye is in the blood. The baby will have an intravenous line which can be used for the blood samples and will not need to be stick for the blood samples. Several radiologists will evaluate the images. The family doctor will be contacted to find out what was the diagnosis and treatment after the results of the MRI were known. Six months after the study, the parent(s)/legal guardian(s) will be contacted to make sure the that baby did not have any problems, especially with the skin, joints and eyes.

Read the detailed description

In order to minimize bias in assessment of the images, blinded reading of the MR images will be performed by 2 blinded readers. The blinded readers will be independent board-certified pediatric radiologists who have no knowledge about the subjects and are not affiliated with any of the clinical sites.

Being tested
Gadoxetate disodium (Eovist/Primovist, BAY86-4873)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gadoxetate disodium (Eovist/Primovist, BAY86-4873)Drug

    Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.

Study groups in NCT02084628
Study groupRoleWhat they receive
Gadoxetate disodium (Eovist/Primovist, BAY86-4873)ExperimentalParticipants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
Receives: Drug: Gadoxetate disodium (Eovist/Primovist, BAY86-4873)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images

    Additional diagnostic information such as better delineation of the border of the lesion, better definition of the internal morphology of the lesion, better characterization of the lesion, better definition of the location of the lesion, better assessment of the communication of the lesion with respect to the biliary system obtained from the combined magnetic resonance (MR) images compared with pre-contrast MR images. Number of subjects with additional diagnostic information were recorded and analyzed.

    Measured: Images were taken pre-injection and post-injection (within about 15 minutes)

  2. Number of Subjects With Adverse Events

    An adverse event (AE) was any untoward medical occurrence that is, any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease in a subject or clinical investigation subject after providing written informed consent for participation in the study.

    Measured: From the signing of the informed consent form until the 6 month post MRI follow-up

  3. Number of Subjects With Serious Adverse Events

    An serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

    Measured: From the signing of the informed consent form until the 6 month post MRI follow-up

Secondary outcomes (7)

  1. Number of Lesions Detected for the Pre-contrast Images

    Measured: Images were taken pre-injection

  2. Number of Lesions Detected for the Combined Images

    Measured: Images were taken pre-injection and post-injection (within about 15 minutes)

  3. Contrast Enhancement of the Liver for the Combined Images Assessed by Yes or no Question

    Measured: Images were taken pre-injection and post-injection (within about 15 minutes)

  4. Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question

    Biliary system included

    1. Gall bladder
    2. Cystic duct
    3. Common bile duct
    4. Right main bile duct
    5. Left main bile duct

    Measured: Images were taken pre-injection and post-injection (within about 15 minutes)

  5. Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question

    Measured: Images were taken pre-injection and post-injection (within about 15 minutes)

  6. Change in Diagnosis for the Combined Images Compared With Precontrast Images

    Diagnosis based on the pre-contrast images will be indicated. If there is a change in the diagnosis based on the combined images, then the combined images diagnosis will be recorded.

    Measured: Images were taken pre-injection and post-injection (within about 15 minutes)

  7. Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question

    Diagnostic confidence was classified as not confident (No), confident (Yes), very confident (Yes).

    Measured: Images were taken pre-injection and post-injection (within about 15 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completionAug 2015
  4. Study completionAug 2015

Why it stopped: Enrollment discontinued due to rare medical condition in the age group 0 to 2 months

Resources

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 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02084628
Sponsor's protocol ID
16078
Other IDs
2012-000952-32
Status last verified
Aug 2016
First submitted
6 Feb 2014
Last updated
23 Sep 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gadoxetate disodium (Eovist/Primovist, BAY86-4873) in people with Magnetic Resonance Imaging, run by Bayer at 9 sites 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 3 inclusion and 6 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2016). 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?

Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images (time frame: Images were taken pre-injection and post-injection (within about 15 minutes)). The study lists 3 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 NCT02084628.

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 23 Sep 2016.

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