Liver Fat and Iron Quantification MRI

Free-Breathing Liver Fat and Iron Quantification Using 3D Stack-of-Radial MRI

The objective of this study is to develop and evaluate novel magnetic resonance imaging (MRI) protocols for studying the structure and function of the human body using 1.5 Tesla and 3.0 Tesla MRI scanners with or without the use of an MRI contrast agent.

Study Overview

• Status: Completed
• Conditions: Liver Diseases
• Intervention / Treatment: Diagnostic test: Magnetic Resonance Imaging (MRI)

Detailed Description

This study will include on-going technical development work for the non-invasive diagnosis of liver fat or iron accumulation and other abnormalities. MRI is a non-invasive imaging technique with no known side effects. The study will utilize imaging equipment that is used routinely in numerous hospitals and clinics around the world.

The project seeks to address optimization of the imaging methodology at 1.5 Tesla and 3.0 Tesla in the liver and abdomen in order to improve clinical evaluation and care of future patients. Non contrast MRI studies will be performed in normal healthy subjects. In addition, the study will include subjects with confirmed disease or who have suspicion for disease, and are undergoing contrast or non-contrast MR imaging as part of their standard of care. Up to sixty-five (65) male or female subjects eighteen years of age and older will be studied in total (number includes healthy subjects and non-healthy subjects).

Currently, clinical MRI exams are of adequate spatial and temporal resolution, sufficient quantitative accuracy, and acceptable exam duration, but improvements in each of these areas would benefit the care of future patients. For example, improvements in spatial and temporal resolution may confer greater conspicuity of disease and shortening the exam duration can be expected to improve patient acceptance and minimize motion artifacts. The study explores innovative ideas about ways to improve MRI exams to have impact in all three of these areas.

Current MRI techniques for fat and iron quantification in the liver and abdomen are challenged by respiratory and organ motion. As a result, imaging parameters (coverage, resolution, etc) and TE (echo time) selection for fat/iron quantification are compromised to accommodate a short breath-held 2D or 3D scan, which can still be affected by motion artifacts and even unachievable for patients with limited breath-holding capability. Therefore, the study aims to achieve robust free-breathing fat/iron quantification in the liver and abdomen using innovative MRI techniques and algorithms.

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • University of California Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will enroll healthy volunteers over age 18 and clinical patients who are scheduled to undergo a clinically indicated MRI of the abdomen or who are willing to undergo a separate research scan.

Description

Inclusion Criteria:

1. Healthy Volunteers:

   • Healthy subjects 18 years or older

2. Clinical Patients:

   • Patients who are 18 years or older and who are scheduled for a routine clinically indicated MRI exam at University of California Los Angeles

Exclusion Criteria:

1. Healthy Volunteers:

   • Age less than 18 years

   • Subject with the following devices/implants/conditions will be excluded:

     1. cardiac pacemakers
     2. defibrillators
     3. cochlear implants
     4. intraocular metallic foreign bodies
     5. intracranial aneurysm clips
     6. claustrophobia
   • Subjects will be excluded if they have a history of severe renal disease (Creatinine level >2.5 mg/dl or Glomerular Filtration Rate <15 ml/minute/1.73m2 ) or allergy to MRI contrast agents ("dyes"). Healthy volunteers will not be studied with these agents.
   • Pregnant subjects will not be enrolled. Although there is no data to suggest that MRI is harmful to the fetus, this study is limited to non-pregnant subjects.

2. Clinical Patients:

   • Age less than 18 years

   • Subject with the following devices/implants/conditions will be excluded:

     1. cardiac pacemakers
     2. defibrillators
     3. cochlear implants
     4. intraocular metallic foreign bodies
     5. intracranial aneurysm clips
     6. claustrophobia
   • Subjects will be excluded if they have a history of severe renal disease (Creatinine level >2.5 mg/dl or Glomerular Filtration Rate <15 ml/minute/1.73m2 ) or allergy to MRI contrast agents ("dyes").
   • Pregnant subjects will not be enrolled. Although there is no data to suggest that MRI is harmful to the fetus, this application is limited to non-pregnant subjects.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Subjects; Healthy volunteers will undergo 60 minute non-contrast enhanced Magnetic Resonance Imaging (MRI) of the abdomen using novel imaging sequences.	Diagnostic test: Magnetic Resonance Imaging (MRI); Magnetic resonance imaging (MRI) is a non-invasive imaging technique that uses a magnetic field and radio waves to create detailed images of the organs and tissues within the body.; Other Names: MR
Clinical Patients; Patients in whom an MRI is indicated for their disease condition will undergo the clinical scan, followed by up to 30 minutes non-contrast enhanced Magnetic Resonance Imaging (MRI) of the abdomen using novel imaging sequences. Clinical patients may also elect to undergo a research only scan of approximately one hour.	Diagnostic test: Magnetic Resonance Imaging (MRI); Magnetic resonance imaging (MRI) is a non-invasive imaging technique that uses a magnetic field and radio waves to create detailed images of the organs and tissues within the body.; Other Names: MR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proton Density Fat Fraction (0 to 100%) in the liver of each subject	MRI based measurement of liver fat content using proton density fat fraction	2 years
Transverse Magnetization Relaxation Rate R2* (1/sec) in the liver of each subject	MRI based measurement of R2* is associated with underlying liver iron content	2 years

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Siemens Corporation, Corporate Technology
• Investigators: Principal Investigator: Holden H Wu, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 24, 2017
• Primary Completion (ACTUAL): May 3, 2021
• Study Completion (ACTUAL): May 3, 2021

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (ACTUAL): May 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: MRI; magnetic resonance imaging; fat quantification; iron quantification
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: 17-000276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No