Liver DiseaseMREINCT02201472

Magnetic Resonance Elastography in Infants

A study testing MRI with MRE in people with Liver Disease, run by Children's Hospital Medical Center, Cincinnati.

Terminated

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

Official record

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Trial summary

MRI \& MRE in infants Read more about this study

Who is it for?: Ages Up to 6 months
Conditions the study is for: Liver Disease
What is being tested?: MRI with MRE
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: No sites listed yet
Study dates: Aug 2014to Aug 2015
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 Up to 6 months
All sexes
No healthy volunteers
Child

Who may be able to join

Infants < 6 months of age
Known liver disease based (liver enzymes, bilirubin, and/or GGT at least twice the upper limit of normal for age)
Parental/LAR permission obtained

Who cannot join

Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
Severe coagulopathy (INR > 3 or platelets <50,000)

About this study

MRI \& MRE in infants

Read the detailed description

The purpose of the present pilot study is to determine the feasibility of using MRI and MRE to evaluate the liver in infants with suspected liver disease.

Conditions: Liver Disease
Being tested: MRI with MRE
Keywords: liver, mre, mri, neonatal, mr touch
Medical subject headings: Liver Diseases

What participants receive

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

MRI with MREDevice
Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device

Study groups in NCT02201472
Study group	Role	What they receive
MRI with MRE	Experimental	Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device Receives: Device: MRI with MRE

What is being measured

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

Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population
To determine the feasibility of MRE to provide evaluable images that illustrate the stiffness of liver parenchyma in an infant population.
Measured: 12 months

Timeline

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

Aug 2014Aug 2015

First posted28 Jul 2014 (estimated)
Study startAug 2014
Primary completionAug 2015
Study completionAug 2015

Why it stopped: Change of research focus

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.
Other trials for Liver DiseaseStudies of the same condition, open and under way.
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
Model description: Magnetic resonance elastography on infants with suspected liver disease
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02201472
Sponsor's protocol ID: 2014-3065
Acronym: MREI
Status last verified: Feb 2017
First submitted: 23 Jul 2014
Last updated: 1 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Magnetic Resonance Elastography in Infants
ClinicalTrials.gov ID: NCT02201472
Acronym / sponsor ID: MREI / 2014-3065
Conditions: Liver Disease
Keywords: liver, mre, mri, neonatal, mr touch
Study type: Interventional
Recruitment status: TerminatedReason stopped: Change of research focus
Enrolment: 2 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Study start: Aug 2014
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 28 Jul 2014 (estimated)
Results: Posted 1 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

MRI \& MRE in infants

Detailed description

The purpose of the present pilot study is to determine the feasibility of using MRI and MRE to evaluate the liver in infants with suspected liver disease.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Magnetic resonance elastography on infants with suspected liver disease

Arm	Type	Receives
MRI with MRE	Experimental	Device: MRI with MREMagnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device

Who may qualify

Ages: Up to 6 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Infants < 6 months of age
Known liver disease based (liver enzymes, bilirubin, and/or GGT at least twice the upper limit of normal for age)
Parental/LAR permission obtained

Key exclusion criteria (2 listed)

Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
Severe coagulopathy (INR > 3 or platelets <50,000)

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 with MREMagnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device	Device	MRI with MRE

Primary outcome

Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population
Time frame: 12 months
To determine the feasibility of MRE to provide evaluable images that illustrate the stiffness of liver parenchyma in an infant population.

Results and safety

Results posted to the registry on 1 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MRI With MRE	2	0

Primary outcome: Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population

Time frame: 12 months

Population analysed: There were too few eligible candidates that clinically would benefit enough to justify the potential risk of being removed from the unit and undergoing MRE in a Radiology department scanner, so the study was terminated with only 2 patients enrolled.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MRI With MRE	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): Due to difficulty with finding neonates who met the inclusion/exclusion criteria who were safe to leave the NICU and go to the Radiology department, the study was terminated and data from the 2 participants enrolled was not analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Liver Disease

Enrolling by invitationPhase 2/3
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
Primary Biliary Cholangitis (PBC)
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
RecruitingPhase 2
Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions
Hepatitis B, Chronic
Active, not recruitingPhase 1/2
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection

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.

Stephanie Merhar, MD principal investigator

Children's Hospital Medical Center, Cincinnati

Questions about this trial

What is this clinical trial studying?

A study testing MRI with MRE in people with Liver Disease, run by Children's Hospital Medical Center, Cincinnati.

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 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: stopped early, as of the sponsor's last update on 1 Sep 2020. 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 1 Sep 2020). 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?

Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population (time frame: 12 months). 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 NCT02201472.

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 1 Sep 2020.