Liver DiseasesNCT03235414
Normal Liver Stiffness by MR Elastography
A study testing MRI and Blood draw in people with Liver Diseases, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR elastography to determine normal liver stiffness values. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- What is being tested?
- MRI and Blood draw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2018to 24 Jul 2020
- 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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 7-17 years
- No documented history of liver diseases
- English speaking
Who cannot join
- NPO less than 4 hours
- Body mass index <10th or > 85th percentile for age
- Documented history of liver disease
- Pregnancy
- Inability to lie still for duration of the MRI
- Inability to breath hold for the duration of the 15-20 second MR elastography sequence
Show all 10Show fewer
- Standard contraindication to MRI (implanted hardware, etc.)
- Requirement of sedation or general anesthesia for MRI
- Abnormality of any measured liver function test
- Liver fat fraction >5% by MRI PDFF
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Determination of Normal Liver Stiffness by MR Elastography in Children
Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR elastography to determine normal liver stiffness values.
Read the detailed description
MR elastography (MRE) is playing a growing role in the non-invasive diagnosis and monitoring of liver disease in the pediatric population. There is, however, little data specific to the use of this technique in children with existing data and techniques largely extrapolated from adult studies. Existing studies suggest that liver stiffness values may be different between children and adults [Etchell, Xanthakos]. As such there is an unmet need for uniquely pediatric data in both healthy and diseased cohorts. To address the need for such data, the investigators plan a multi-site, prospective study of healthy pediatric (<18 years of age) volunteers to determine normal liver stiffness measured by MR elastography across the range of MRI equipment.
- Conditions
- Liver Diseases
- Being tested
- MRI, Blood draw
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Will receive a one time research MRI (MR elastography)
Blood drawDiagnostic test
Will receive a one time blood draw to confirm healthy liver status
| Study group | Role | What they receive |
|---|---|---|
| Normals | Experimental | Will receive an MRI and a blood draw Receives: Device: MRI; Diagnostic Test: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Stiffness
Liver stiffness is a measure of a mechanical property of tissue (stiffness). This can be measured non-invasively by MR elastography, a technique that involves applying an external vibration to the abdomen and measuring the progression of shear waves through the underlying liver using MRI.
Purpose of the study was to determine normal (healthy) liver stiffness as measured by MRE
Measured: 30 minutes
Secondary outcomes (3)
Cross-platform Variability
To assess for cross-platform (different MRI vendors) variability in normal MRI liver stiffness values
Measured: 30 minutes
Cross-field Strength
To assess cross-field strength (1.5T vs. 3T) variability in normal MRI liver stiffness values
Measured: 30 minutes
Sex-related Differences
To assess for sex-related (male vs. female) differences in normal MRI liver stiffness values
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start19 Feb 2018
- Primary completion25 Jun 2020
- Study completion24 Jul 2020
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 DiseasesStudies 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
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Washington University School of Medicine, Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Andrew Trout, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235414
- Sponsor's protocol ID
- CIN001-Liver stiffness
- Status last verified
- Jun 2026
- First submitted
- 28 Jul 2017
- Last updated
- 24 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Trout AT, Anupindi SA, Gee MS, Khanna G, Xanthakos SA, Serai SD, Baikpour M, Calle-Toro JS, Ozturk A, Zhang B, Dillman JR. Normal Liver Stiffness Measured with MR Elastography in Children. Radiology. 2020 Dec;297(3):663-669. doi: 10.1148/radiol.2020201513. Epub 2020 Sep 22.
PubMed 32960728
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Normal Liver Stiffness by MR Elastography in Children
- ClinicalTrials.gov ID
- NCT03235414
- Acronym / sponsor ID
- CIN001-Liver stiffness
- Conditions
- Liver Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Washington University School of Medicine, Children's Hospital of Philadelphia
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Posted 27 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR elastography to determine normal liver stiffness values.
Detailed description
MR elastography (MRE) is playing a growing role in the non-invasive diagnosis and monitoring of liver disease in the pediatric population. There is, however, little data specific to the use of this technique in children with existing data and techniques largely extrapolated from adult studies. Existing studies suggest that liver stiffness values may be different between children and adults [Etchell, Xanthakos]. As such there is an unmet need for uniquely pediatric data in both healthy and diseased cohorts. To address the need for such data, the investigators plan a multi-site, prospective study of healthy pediatric (<18 years of age) volunteers to determine normal liver stiffness measured by MR elastography across the range of MRI equipment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normals | Experimental | Device: MRI, Diagnostic Test: Blood drawWill receive an MRI and a blood draw |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 7-17 years
- No documented history of liver diseases
- English speaking
Key exclusion criteria (10 listed)
- NPO less than 4 hours
- Body mass index <10th or > 85th percentile for age
- Documented history of liver disease
- Pregnancy
- Inability to lie still for duration of the MRI
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 |
|---|---|---|
| MRIWill receive a one time research MRI (MR elastography) | Device | Normals |
| Blood drawWill receive a one time blood draw to confirm healthy liver status | Diagnostic test | Normals |
Primary outcome
Liver Stiffness
Time frame: 30 minutes
Liver stiffness is a measure of a mechanical property of tissue (stiffness). This can be measured non-invasively by MR elastography, a technique that involves applying an external vibration to the abdomen and measuring the progression of shear waves through the underlying liver using MRI. Purpose of the study was to determine normal (healthy) liver stiffness as measured by MRE
3 secondary outcomes
Cross-platform Variability
Time frame: 30 minutes
Cross-field Strength
Time frame: 30 minutes
Sex-related Differences
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32960728Trout AT, Anupindi SA, Gee MS, Khanna G, Xanthakos SA, Serai SD, Baikpour M, Calle-Toro JS, Ozturk A, Zhang B, Dillman JR. Normal Liver Stiffness Measured with MR Elastography in Children. Radiology. 2020 Dec;297(3):663-669. doi: 10.1148/radiol.2020201513. Epub 2020 Sep 22.
- Individual participant dataSharing planned: No
Related trials for Liver Diseases
RecruitingPhase 1/2
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Metastatic Melanoma, Liver Metastases
Not yet recruitingObservational study
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
Primary Biliary Cholangitis (PBC)
RecruitingObservational study
Conventional Ultrasound Versus Remote Ultraportable ulTrasound in the Context of Viral Hepatitis
Hepatitis, Teleradiology
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
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.
Andrew Trout, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and Blood draw in people with Liver Diseases, run by Children's Hospital Medical Center, Cincinnati 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 3 inclusion and 10 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 24 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 27 Aug 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?
Liver Stiffness (time frame: 30 minutes). 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 NCT03235414, 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 24 Jul 2026.