Liver Fat and Iron Quantification MRI

April 28, 2022 updated by: Holden H. Wu, PhD, University of California, Los Angeles

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proton Density Fat Fraction (0 to 100%) in the liver of each subject
Time Frame: 2 years
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
Time Frame: 2 years
MRI based measurement of R2* is associated with underlying liver iron content
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Siemens Corporation, Corporate Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Holden H Wu, PhD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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