Comparison of MR Elastography Methods Without and With Compressed Sensing

NCT03260660 | Completed

• 1 other identifier: CIN_CompMRE_001
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

In this research study, the investigators will compare the liver stiffness results obtained from the current Magnetic Resonance Imaging (MRI) method to liver stiffness results obtained from a method that uses faster imaging techniques.

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (3)

• Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x1.5)

  Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 1.5 times the amount of standard Sensing applied. Correlation Coefficient will be determined for resulting elastography data.

  30 minutes

• Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x2)

  Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 2 times the amount of standard sensing applied. correlation coefficient will be determined for resulting elastography data.

  30 minutes

• Standard Magnetic Resonance Elastography versus Elastography with Compressed Sensing (x3)

  Four MR elastography images through the mid liver will be obtained using standard MR elastography and MR elastography with 3 times the amount of standard Sensing applied. Correlation coefficient will be determined for resulting elastography data.

  30 minutes

Secondary Outcomes (2)

• Standard Magnetic Resonance Elastography versus respiratory triggered Magnetic Resonance Elastography.

  30 minutes

• Standard Magnetic Resonance Elastography versus navigated triggered Magnetic Resonance Elastography.

  30 minutes

Interventions

Magnetic Resonance Elastography DEVICE

The investigators plan to prospectively assess the agreement of liver stiffness measurements obtained using standard of care MR elastography techniques vs. MR elastography with varying amounts of imaging acceleration using compressed sensing in adult volunteers

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

You may qualify if:

• Adult volunteers ≥18 years of age
• Ability to tolerate 30 minutes in an MRI scanner.
• Nothing to eat or drink for 4 hours prior to the MRI scan

You may not qualify if:

• No contraindication to MR imaging (e.g., implanted non-MRI compatible device)
• Known or suspected pregnancy. Female subjects of child bearing potential will undergo a urine pregnancy test prior to imaging.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jonathan Dillman, MD,MSc

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 24, 2017
• Study Start: August 15, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 29, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)