NCT03027700

Brief Summary

The goal of this study is to learn more about liver fibrosis and methods to detect it. We will evaluate and compare multiple MRI based measures of liver fibrosis in subjects with and without liver disease.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

January 26, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

January 19, 2017

Last Update Submit

January 27, 2020

Conditions

Liver FibrosesHepatic Steatosis

Outcome Measures

Primary Outcomes (1)

  • MR imaging vs. histologic scoring in hepatic fibrosis

    Correlate the results from the different imaging sequences designed to detect and quantify hepatic fibrosis

    2 years

Secondary Outcomes (1)

  • MRI reproducibility

    2 years

Study Arms (4)

Health/Normal Controls

ACTIVE COMPARATOR

Health/normal control subjects will undergo MRI using several different imaging sequences (MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer) designed to detect and quantify hepatic fibrosis.

Device: MRI

F1/F2 fibrosis

ACTIVE COMPARATOR

Type 1 and 2 liver fibrosis subjects will undergo MRI using several different imaging sequences (MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer) designed to detect and quantify hepatic fibrosis.

Device: MRI

F3/F4 fibrosis

ACTIVE COMPARATOR

Type 2 and 3 liver fibrosis subjects will undergo MRI using several different imaging sequences (MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer) designed to detect and quantify hepatic fibrosis.

Device: MRI

Hepatic steatosis with fibrosis

ACTIVE COMPARATOR

Hepatic steatosis with liver fibrosis subjects will undergo MRI using several different imaging sequences (MR Elastography, T1 mapping, T2 mapping, T1 rho, and magnetization transfer) designed to detect and quantify hepatic fibrosis.

Device: MRI

Interventions

MRIDEVICE

MRI scan performed on 1.5T Philips Ingenia MRI scanner.

F1/F2 fibrosisF3/F4 fibrosisHealth/Normal ControlsHepatic steatosis with fibrosis

Eligibility Criteria

Age8 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Group 1:
  • Healthy subjects with no known or suspected liver disease
  • Age 8 - 21 years
  • Groups 2 and 3:
  • Biopsy confirmed liver fibrosis (F1/F2 Group 2, F3/F4 Group 3)
  • Age 8 - 21 years
  • Group 4:
  • Biopsy confirmed hepatic steatosis AND biopsy confirmed liver fibrosis (any stage)
  • Age 8 - 21 years

You may not qualify if:

  • All subjects:
  • Subjects \<8 years of age and \>21 years of age.
  • BMI \> 35 kg/m2
  • Subjects deemed to possibly require sedation to undergo MR imaging
  • Inability to lie still for 90 minutes
  • Pregnancy (verbal pregnancy screens - per standard practice in Radiology - will be administered to all female participants of child-bearing age at the time of enrollment and again immediately prior to imaging)
  • Prior history of liver transplantation
  • Group 1
  • ALT ≥30 U/L
  • Clinical history or lab/biopsy results suggestive of the presence of liver disease including: steatosis, fibrosis, inflammation, tumor, etc.
  • Group 2 and 3
  • Diagnosis of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis
  • Biopsy \>6 months prior to research MRI examination
  • Initiation of any medications (e.g. steroids, immunosuppressants, antivirals) or procedures (e.g. Kasai portoenterostomy) to treat the liver disease during the time between liver biopsy and study visit
  • Group 4
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (2)

  • Sporea I, Bota S, Jurchis A, Sirli R, Gradinaru-Tascau O, Popescu A, Ratiu I, Szilaski M. Acoustic radiation force impulse and supersonic shear imaging versus transient elastography for liver fibrosis assessment. Ultrasound Med Biol. 2013 Nov;39(11):1933-41. doi: 10.1016/j.ultrasmedbio.2013.05.003. Epub 2013 Aug 9.

    PMID: 23932281BACKGROUND

  • Xanthakos SA, Podberesky DJ, Serai SD, Miles L, King EC, Balistreri WF, Kohli R. Use of magnetic resonance elastography to assess hepatic fibrosis in children with chronic liver disease. J Pediatr. 2014 Jan;164(1):186-8. doi: 10.1016/j.jpeds.2013.07.050. Epub 2013 Sep 21.

    PMID: 24064151BACKGROUND

MeSH Terms

Conditions

Liver CirrhosisFatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2017

First Posted

January 23, 2017

Study Start

January 26, 2017

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)