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
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Condition or disease | Intervention/treatment |
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Liver Diseases | Diagnostic Test: Magnetic Resonance Imaging (MRI) |
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 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 |

Group/Cohort | Intervention/treatment |
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Healthy Subjects
Healthy volunteers will undergo 60 minute non-contrast enhanced Magnetic Resonance Imaging (MRI) of the abdomen using novel imaging sequences.
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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 |
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
Inclusion Criteria:
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Healthy Volunteers:
- Healthy subjects 18 years or older
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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:
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Healthy Volunteers:
- Age less than 18 years
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Subject with the following devices/implants/conditions will be excluded:
- cardiac pacemakers
- defibrillators
- cochlear implants
- intraocular metallic foreign bodies
- intracranial aneurysm clips
- 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.
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Clinical Patients:
- Age less than 18 years
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Subject with the following devices/implants/conditions will be excluded:
- cardiac pacemakers
- defibrillators
- cochlear implants
- intraocular metallic foreign bodies
- intracranial aneurysm clips
- 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.

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
Contact: Tammy L Floore, BSN | 310-794-9202 | tfloore@mednet.ucla.edu | |
Contact: Saima Chaabane, PhD | 310-794-8995 | schaabane@mednet.ucla.edu |
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 |
Principal Investigator: | Holden H Wu, PhD | University of California, Los Angeles |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
MRI magnetic resonance imaging fat quantification iron quantification |
Liver Diseases Digestive System Diseases Iron Trace Elements |
Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |