Normal Liver Stiffness by MR Elastography

NCT03235414 | Completed Results FDA Device

• 1 other identifier: CIN001-Liver stiffness
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR elastography to determine normal liver stiffness values.

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (1)

• 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

  During investigation

Secondary Outcomes (3)

• Cross-platform Variability

  During Investigation

• Cross-field Strength

  During investigation

• Sex-related Differences

  During investigation

Study Arms (1)

Normals

EXPERIMENTAL

Will receive an MRI and a blood draw

Device: MRI; Diagnostic Test: Blood draw

Interventions

MRI DEVICE

Will receive a one time research MRI (MR elastography)

Normals

Blood draw DIAGNOSTIC_TEST

Will receive a one time blood draw to confirm healthy liver status

Normals

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 7-17 years
• No documented history of liver diseases
• English speaking

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Massachusetts General Hospital: collaborator
• Washington University School of Medicine: collaborator
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 32960728 DERIVED

MeSH Terms

Conditions

Liver Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Andrew Trout
• Organization: Cincinnati Children's Hospital Medical Center; Department of Radiology

andrew.trout@cchmc.org

513-803-3004

Study Officials

• Andrew Trout, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: July 28, 2017
• First Posted: August 1, 2017
• Study Start: February 19, 2018
• Primary Completion: June 25, 2020
• Study Completion: July 24, 2020
• Last Updated: September 16, 2020
• Results First Posted: August 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)