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AzTrials

Autoimmune Liver DiseaseNCT03175471

MRI Based Biomarkers in Pediatric Autoimmune Liver Disease

An observational study of Autoimmune Liver Disease and Primary Sclerosing Cholangitis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factors for chronic liver disease among adolescents. Read more about this study

Who is it for?
Ages 6 to 23 years
How many people
115 participants
Where
1 siteUnited States
Study dates
17 Jan 2017to 30 Jan 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 6 to 23 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: A total of 115 patients between 6 and 23 years of age with a diagnosis of PSC or AIH will be enrolled.

Who may be able to join

  • Age 6-23 years old.
  • Established or suspected clinical diagnosis of AIH or PSC.

Who cannot join

  • History of liver transplantation.
  • Chronic Hepatitis B or untreated hepatitis C virus infection.
  • Pregnancy.
  • Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).
  • Diagnosis of cystic fibrosis or biliary atresia
  • Diagnosis of cardiac hepatopathy.
  • Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease.
  • Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alexander Miethke, MD contact

513-636-8948

Alexander.Miethke@cchmc.org

Cyd Castro Rojas, PhD contact

513-517-0580

Cyd.CastroRojas@cchmc.org

United States1 site, 1 recruiting

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio, 45229

    Alexander Miethke, MD, 513-636-5581, Alexander.Miethke@cchmc.org

    Alexander Miethke, MD

    Recruiting

Other trials in United States

About this study

Official title: Cross-sectional Study for Assessment of MRI Based Biomarkers of Bile Duct Injury and Hepatic Fibrosis in Pediatric Onset Autoimmune Liver Disease

Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factors for chronic liver disease among adolescents. In all these conditions, autoimmune lymphocyte responses are thought to orchestrate inflammatory injury against hepatocytes (primarily in AIH) or cholangiocytes (in PSC). In this proposal we aim to evaluate the Magnetic Resonance Imaging (MRI) modalities; MR cholangiopancreatography (MRCP) and MR elastography (MREL), as non-invasive biomarkers to assess two primary pathophysiological processes of AILD: bile duct damage and liver fibrosis. In this cross-sectional study MRI based findings of bile duct injury and liver fibrosis will be correlated with both liver histology and circulating biomarkers of these disease processes.

Medical subject headings
Cholangitis, Sclerosing, Hepatitis, Autoimmune

What participants receive

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

Study groups in NCT03175471
Study groupRoleWhat they receive
Patients with autoimmune liver diseasePatients (6-23 y.o.) with established clinical diagnosis of AIH or suspected diagnosis of AIH based on elevated serum AST or ALT, elevated IgG level >1.1 ULN, elevated titer of autoantibodies, including ANA, SMA, LKM, LC-1 or SLA, which is consistent with the simplified criteria for the diagnosis of AIH in children will be enrolled. Patients (6-23 y.o.) with established clinical diagnosis of PSC or Suspected diagnosis of PSC supported by abnormal cholangiogram (ERCP or MRCP) or elevated GGT>1.5 ULN and dilated bile ducts by liver ultrasound will be enrolled.

What is being measured

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

  1. MRI based outcomes

    MRCP based assessment of intrahepatic and extrahepatic duct irregularities by Majoie classification (on 4 and 5 point scale of 0-3 and 0-4 respectively; 0: No visible abnormalities, 1: minimal dilatation/irregularities, 2: saccular dilatations/segmental stricture, 3: severe pruning, 4: Extremely irregular margin).

    MREL based quantification of mean shear stiffness (kPa) of liver.

    Measured: 36 months

  2. Liver histopathology based assessment of bile duct injury by ISHAK Score

    Assessment of bile duct injury by ISHAK Score (Confluent necrosis: on the 7 point scale of 0-6; Focal necrosis on the 4 point scale of 0-4 and portal inflammation on the 4 point scale of 0-4).

    Measured: 36 months

  3. Liver histopathology based assessment of bile duct injury by Ludwig score

    Assessment of bile duct injury by Ludwig score (on five point scale of 0-4; 0: No ductal injury, 1: portal inflammation, 2: periportal inflammation, 3: Portal bridging, 4: Nodular cirrhosis).

    Measured: 36 months

  4. Liver histopathology based assessment of liver fibrosis by Nakanuma score

    Assessment of liver fibrosis by Nakanuma score for on the 4 point scale of 0-3 (0; No portal fibrosis, 1; Portal fibrosis; 2; Bridging fibrosis, 3; Liver cirrhosis) .

    Measured: 36 months

  5. Liver histopathology based assessment of liver fibrosis by Ishak score

    Assessment of liver fibrosis by Ishak score on the 7 point scale of 0-6 (0; Absent, 1; confluent necrosis, 2; necrosis in some areas, 3; necrosis in most areas, 4; necrosis with occasional portal-central bridging necrosis, 5; necrosis with multiple portal-central bridging necrosis, 6; Panacinar or multiacinar necrosis).

    Measured: 36 months

  6. Liver histopathology based assessment of cholangitis and hepatic activity

    Cholangitis and hepatic activity by Nakanuma score for on the 4 point scale of 0-3 (0; No bile duct loss, 1; Bile duct loss in <1/3 of portal tracts; 2; Bile duct loss in 1/3-2/3 of portal tracts, 3; Bile duct loss in >2/3 of portal tracts).

    Measured: 36 months

  7. Serum based outcome

    Quantification of serum alkaline phosphatase (ALP in U/L) and Gamma-glutamyl transpeptidase (GGT in U/L).

    Measured: 36 months

  8. Enhanced Liver Fibrosis (ELF) score

    Assesment of Enhanced Liver Fibrosis (ELF) score on continuous scale of 1-10; <7.7 none -mild. ≥7.7 -<9.8 moderate, >9.8 sever).

    Measured: 36 months

Secondary outcomes (5)

  1. MR T1rho, T1, T2 Imaging

    Mean of MR T1rho, T1, T2 signal in msec to measure the inflammation.

    Measured: 36 Months

  2. Liver Morphometry

    Collagen deposition in percent area fibrosis by image analysis

    Measured: 36 Months

  3. Liver histopathology based outcomes

    Liver histopathology based grade of inflammation by Scheuer score on 5 point scale of 0-4; (0: No ductal injury, 1: portal inflammation, 2: periportal inflammation, 3: Portal to portal bridging, 4: Nodular cirrhosis).

    Measured: 36 Months

  4. Serum based outcomes

    Quantification of serum fractionated ALP (U/L)

    Measured: 36 Months

  5. Serum MMP7

    Quantification of serum MMP7 (pg/mL)

    Measured: 36 Months

Timeline

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

  1. First posted5 Jun 2017
  2. Study start17 Jan 2017
  3. Primary completion30 Jan 2030 (estimated)
  4. Study completion30 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
115 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03175471
Sponsor's protocol ID
CIN001-MRI biomarkers in AILD
Status last verified
Aug 2026
First submitted
31 Jan 2017
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mahalingam N, Trout AT, Zhang B, Castro-Rojas C, Miethke AG, Dillman JR. Longitudinal changes in quantitative magnetic resonance imaging metrics in children and young adults with autoimmune liver disease. Abdom Radiol (NY). 2023 Jun;48(6):1933-1944. doi: 10.1007/s00261-022-03733-9. Epub 2023 Feb 17.

    PubMed 36799997

  • McCrary J, Trout AT, Mahalingam N, Singh R, Rojas CC, Miethke AG, Dillman JR. Associations Between Quantitative MRI Metrics and Clinical Risk Scores in Children and Young Adults With Autoimmune Liver Disease. AJR Am J Roentgenol. 2022 Jul;219(1):142-150. doi: 10.2214/AJR.21.27204. Epub 2022 Jan 26.

    PubMed 35080454

  • Dillman JR, Trout AT, Taylor AE, Khendek L, Kasten JL, Sheridan RM, Sharma D, Karns RA, Castro-Rojas C, Zhang B, Miethke AG. Association Between MR Elastography Liver Stiffness and Histologic Liver Fibrosis in Children and Young Adults With Autoimmune Liver Disease. AJR Am J Roentgenol. 2024 Jul;223(1):e2431108. doi: 10.2214/AJR.24.31108. Epub 2024 Apr 17.

    PubMed 38630086

Questions about this trial

What is this clinical trial studying?

An observational study of Autoimmune Liver Disease and Primary Sclerosing Cholangitis, 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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 Aug 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexander Miethke, MD (513-636-8948, Alexander.Miethke@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI based outcomes (time frame: 36 months). The study lists 8 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 NCT03175471, which also lists 3 linked publications.

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 19 Aug 2026.

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