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Liver Fat and Iron Quantification MRI

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ClinicalTrials.gov Identifier: NCT03162302
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Siemens Corporation, Corporate Technology
Information provided by (Responsible Party):
Holden H. Wu, PhD, University of California, Los Angeles

Study Description
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Brief Summary:
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 1.5Tesla and 3.0Tesla MRI scanners with or without the use of an MRI contrast agent.

Condition or disease Intervention/treatment
Liver Diseases 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 fourty-two (42) 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 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 Design
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Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Free-Breathing Liver Fat and Iron Quantification Using 3D Stack-of-Radial MRI
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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 Name: 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.
 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 Name: MR


Outcome Measures
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Primary Outcome Measures :
  1. 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. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162302


Contacts
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Contact: Tammy L Floore, BSN 310-794-9202 tfloore@mednet.ucla.edu
Contact: Saima Chaabane, PhD 310-794-8995 schaabane@mednet.ucla.edu

Locations
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United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90024
Contact: Tammy Floore, RN    310-794-9202    tfloore@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Siemens Corporation, Corporate Technology
Investigators
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Principal Investigator: Holden H Wu, PhD University of California, Los Angeles
More Information
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Responsible Party: Holden H. Wu, PhD, Assistant Professor-in-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03162302     History of Changes
Other Study ID Numbers: 17-000276
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Holden H. Wu, PhD, University of California, Los Angeles:
MRI
magnetic resonance imaging
fat quantification
iron quantification
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Iron
Trace Elements
 Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs