Liver DiseasesNCT03162302
Liver Fat and Iron Quantification MRI
An observational study of Liver Diseases, run by University of California, Los Angeles at 1 site in United States.
Trial 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 1.5 Tesla and 3.0 Tesla MRI scanners with or without the use of an MRI contrast agent. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2017to 3 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Healthy Volunteers:
- Healthy subjects 18 years or older
- 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
Who cannot join
- Healthy Volunteers:
- Age less than 18 years
- Subject with the following devices/implants/conditions will be excluded:
- cardiac pacemakers
- defibrillators
- cochlear implants
Show all 22Show fewer
- 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.
- Clinical Patients:
- Age less than 18 years
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90024
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Diseases
- Being tested
- Magnetic Resonance Imaging (MRI)
- Keywords
- MRI, magnetic resonance imaging, fat quantification, iron quantification
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Diagnostic test
Also called MR
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Healthy volunteers will undergo 60 minute non-contrast enhanced Magnetic Resonance Imaging (MRI) of the abdomen using novel imaging sequences. Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI) | |
| 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. Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start24 May 2017
- Primary completion3 May 2021
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Responsible party
- Principal investigator, Holden H. Wu, PhD, University of California, Los Angeles
- Investigators
- Holden H Wu, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162302
- Sponsor's protocol ID
- 17-000276
- Status last verified
- Apr 2022
- First submitted
- 18 May 2017
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free-Breathing Liver Fat and Iron Quantification Using 3D Stack-of-Radial MRI
- ClinicalTrials.gov ID
- NCT03162302
- Acronym / sponsor ID
- 17-000276
- Conditions
- Liver Diseases
- Keywords
- MRI, magnetic resonance imaging, fat quantification, iron quantification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Study start
- 24 May 2017 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | Diagnostic Test: Magnetic Resonance Imaging (MRI)Healthy volunteers will undergo 60 minute non-contrast enhanced Magnetic Resonance Imaging (MRI) of the abdomen using novel imaging sequences. |
| Clinical Patients | – | Diagnostic Test: Magnetic Resonance Imaging (MRI)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Healthy Volunteers:
- Clinical Patients:
Key exclusion criteria (22 listed)
- Healthy Volunteers:
- Clinical Patients:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Also: MRMagnetic 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. | Diagnostic test | Clinical Patients, Healthy Subjects |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holden H Wu, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proton Density Fat Fraction (0 to 100%) in the liver of each subject (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.