NCT02652221

Brief Summary

A prospective, pilot study using acoustic radiation force imaging (ARFI) ultrasound (US) to quantify liver stiffness in children and young adults with chronic liver disease. ARFI results will be compared to the current clinical standard of Magnetic Resonance Elastography (MRE) and to liver biopsy when available.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Status
completed

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

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 12, 2017

Completed
Last Updated

July 12, 2017

Status Verified

June 1, 2017

Enrollment Period

1.5 years

First QC Date

January 4, 2016

Results QC Date

January 31, 2017

Last Update Submit

June 13, 2017

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Agreement in Measured Liver Stiffness Between ARFI and MRE

    The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis

    Within 24 hours

Study Arms (1)

Study cohort

EXPERIMENTAL

Acoustic Radiation Force Imaging

Device: Acoustic Radiation Force Imaging

Interventions

Acoustic Radiation Force ImagingDEVICE

ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness.

Also known as: ARFI
Study cohort

Eligibility Criteria

Age1 Day - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Less than 25 years old with chronic liver disease

You may not qualify if:

  • Subjects without clinically ordered MRE
  • Subjects who cannot cooperate with performance of the short ARFI exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Elasticity Imaging Techniques

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Limitations and Caveats

1)Did not compare ARFI from multiple vendors to MR elastography, 2)No histologic reference standard

Results Point of Contact

Title
Andrew T. Trout, MD
Organization
Cincinnati Children's Hospital Medical Center
andrew.trout@cchmc.org
513-803-3004

Study Officials

  • Andrew Trout, M.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 11, 2016

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

July 12, 2017

Results First Posted

July 12, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share