Non-Alcoholic Fatty Liver DiseaseNAFLDNCT03674528
Technical Validation of MR Biomarkers of Obesity-Associated NAFLD
An observational study of Non-Alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
The overall goal of this collaborative research program is to develop, validate and translate advanced quantitative magnetic resonance (MR) biomarkers of obesity-associated non-alcoholic fatty liver disease (NAFLD). This protocol represents the research plan for two distinct phases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
- What is being tested?
- Magnetic Resonance Elastography (MRE) and Liver biopsy
- How many people
- 152 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 May 2018to 11 Jun 2024
- 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: Phase 1 participants will be healthy adults with a BMI of greater/equal to 35 kilograms per meter squared. Phase 2 participants must be eligible for weight loss surgery and willing to undergo a liver biopsy procedure.
Who may be able to join
- Age of at least 18 years
- Severely obese (BMI ≥ 35 kg/m2) patient
- Cleared for weight-loss surgery
- Willing and able to complete all safety and follow-up procedures
- Willing to allow for the banking of biological samples
Who cannot join
- Contraindications to MRI
- Girth or weight that exceeds scanner capacity
- Women of childbearing potential that are pregnant or will be attempting to become pregnant during the study duration.
- Known liver malignancies
- Regular \& excessive alcohol consumption within 2 years prior to recruitment
- Use of steatogenic or hepatotoxic drugs
- Clinical or laboratory evidence of liver disease other than Nonalcoholic fatty liver disease (NAFLD)/ Nonalcoholic steatohepatitis (NASH) (e.g. HCV Ab, HBV Ab, ceruloplasmin)
- The subject has increased bleeding risk (i.e., decreased platelets, von Willebrand disease)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, San Diego
La Jolla, California, 92093
University of Wisconsin, Madison
Madison, Wisconsin, 53704
About this study
Official title: Technical Validation of Magnetic Resonance Biomarkers of Obesity-Associated Non-Alcoholic Fatty Liver Disease
The overall goal of this collaborative research program is to develop, validate and translate advanced quantitative magnetic resonance (MR) biomarkers of obesity-associated non-alcoholic fatty liver disease (NAFLD). This protocol represents the research plan for two distinct phases. The first phase is an optimization phase. The second phase is designed to complete a rigorous test of conventional and advanced MRE techniques. Complementary anthropometric, laboratory, and MR measures will also be collected to characterize the cohort and identify factors that affect MRE performance
Read the detailed description
The long-term objective of this research is to improve the health of the millions of Americans with or at risk for NAFLD, the most common chronic liver disease and most rapidly growing indication for liver transplantation in the United States. To achieve this objective, an advanced MR-based imaging method will be used to measure liver "stiffness" which is an early sign of disease. This technique has been previously developed and validated and ready to be used for further research. This current protocol will extend previous work by optimizing and validating advanced 2 dimensional and 3 dimensional-magnetic resonance elastography (MRE) methods as non-invasive biomarkers of hepatic inflammation and fibrosis in obese patients at risk for non-alcoholic steatohepatitis (NASH), the histologically more aggressive subset of NAFLD.
Per Amendment approved 4/8/22: MRE exams will be conducted using a PDFF Pocket Phantom purchased by the UCSD from Calimetrix. This phantom consists of vials with known fat fraction which are captured when taking images of the liver. The known fat fractions provide an independent reference and are used for quality assurance purposes.
- Being tested
- Magnetic Resonance Elastography (MRE), Liver biopsy
- Keywords
- MRI, MRE, Liver Disease, Liver Fibrosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Elastography (MRE)Other
Also called MRI
The MRE scan will several breath holds and will take approximately 30 minutes to complete.
Liver biopsyDiagnostic test
Also called Intraoperative Biopsy
Subjects undergoing WLS will be asked to allow for liver biopsy samples to be collected during their surgical procedure. The collection of these samples will take approximately 5 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Subjects with a BMI of 35 or more will be asked to undergo a single MRE imaging session. Receives: Other: Magnetic Resonance Elastography (MRE) | |
| Patient Group | Adults that are candidates for weight loss surgery will be asked to participate in four study visits that include MRE imaging and 1 - 2 liver biopsy procedures. Receives: Other: Magnetic Resonance Elastography (MRE); Diagnostic Test: Liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimization of MRE for 2 dimensional and 3 dimensional methods
Optimize MRE wave-field generation in this subject population to maximize the area of invertible shear waves in the liver into interpretable shear stiffness maps.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start4 May 2018
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), GE Healthcare, Pfizer, Siemens Medical Solutions, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Scott Reeder, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674528
- Sponsor's protocol ID
- 2018-0244
- Other IDs
- 2R01DK088925-06A1, A539300, SMPH/RADIOLOGY/RADIOLOGY, Protocol Version 3/8/2022, 5UL1TR002373-04
- Acronym
- NAFLD
- Status last verified
- Sep 2024
- First submitted
- 3 Jul 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Muller L, Ceriani L, Harris DT, Wolfson T, Batakis D, Agni R, Covarrubias Y, Pepin K, Ehman RL, Heilman J, Panagiotopoulos N, Hamilton G, Middleton MS, Martins VF, Gamst AC, Sappenfield R, Grunvald E, Funk LM, Jacobsen GR, Lidor AO, Goodman JA, Khoury SB, Sirlin CB, Reeder SB. Comparative Precision of 3D MRE and 2D MRE for Measurement of Liver Stiffness in Adults with Severe Obesity. Radiology. 2026 May;319(2):e253243. doi: 10.1148/radiol.253243.
PubMed 42084509
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Validation of Magnetic Resonance Biomarkers of Obesity-Associated Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03674528
- Acronym / sponsor ID
- NAFLD / 2018-0244
- Keywords
- MRI, MRE, Liver Disease, Liver Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), GE Healthcare, Pfizer, Siemens Medical Solutions, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 4 May 2018 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 17 Sep 2018 (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 overall goal of this collaborative research program is to develop, validate and translate advanced quantitative magnetic resonance (MR) biomarkers of obesity-associated non-alcoholic fatty liver disease (NAFLD). This protocol represents the research plan for two distinct phases. The first phase is an optimization phase. The second phase is designed to complete a rigorous test of conventional and advanced MRE techniques. Complementary anthropometric, laboratory, and MR measures will also be collected to characterize the cohort and identify factors that affect MRE performance
Detailed description
The long-term objective of this research is to improve the health of the millions of Americans with or at risk for NAFLD, the most common chronic liver disease and most rapidly growing indication for liver transplantation in the United States. To achieve this objective, an advanced MR-based imaging method will be used to measure liver "stiffness" which is an early sign of disease. This technique has been previously developed and validated and ready to be used for further research. This current protocol will extend previous work by optimizing and validating advanced 2 dimensional and 3 dimensional-magnetic resonance elastography (MRE) methods as non-invasive biomarkers of hepatic inflammation and fibrosis in obese patients at risk for non-alcoholic steatohepatitis (NASH), the histologically more aggressive subset of NAFLD.
Per Amendment approved 4/8/22: MRE exams will be conducted using a PDFF Pocket Phantom purchased by the UCSD from Calimetrix. This phantom consists of vials with known fat fraction which are captured when taking images of the liver. The known fat fractions provide an independent reference and are used for quality assurance purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: Magnetic Resonance Elastography (MRE)Subjects with a BMI of 35 or more will be asked to undergo a single MRE imaging session. |
| Patient Group | – | Other: Magnetic Resonance Elastography (MRE), Diagnostic Test: Liver biopsyAdults that are candidates for weight loss surgery will be asked to participate in four study visits that include MRE imaging and 1 - 2 liver biopsy procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Phase 1 participants will be healthy adults with a BMI of greater/equal to 35 kilograms per meter squared. Phase 2 participants must be eligible for weight loss surgery and willing to undergo a liver biopsy procedure.
Key inclusion criteria (5 listed)
- Age of at least 18 years
- Severely obese (BMI ≥ 35 kg/m2) patient
- Cleared for weight-loss surgery
- Willing and able to complete all safety and follow-up procedures
- Willing to allow for the banking of biological samples
Key exclusion criteria (8 listed)
- Contraindications to MRI
- Girth or weight that exceeds scanner capacity
- Women of childbearing potential that are pregnant or will be attempting to become pregnant during the study duration.
- Known liver malignancies
- Regular \& excessive alcohol consumption within 2 years prior to recruitment
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 Elastography (MRE)Also: MRIThe MRE scan will several breath holds and will take approximately 30 minutes to complete. | Other | Control Group, Patient Group |
| Liver biopsyAlso: Intraoperative BiopsySubjects undergoing WLS will be asked to allow for liver biopsy samples to be collected during their surgical procedure. The collection of these samples will take approximately 5 minutes to complete. | Diagnostic test | Patient Group |
Primary outcome
Optimization of MRE for 2 dimensional and 3 dimensional methods
Time frame: Up to 24 months
Optimize MRE wave-field generation in this subject population to maximize the area of invertible shear waves in the liver into interpretable shear stiffness maps.
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 19 Sep 2024.
- Derived from this study: PubMed 42084509Muller L, Ceriani L, Harris DT, Wolfson T, Batakis D, Agni R, Covarrubias Y, Pepin K, Ehman RL, Heilman J, Panagiotopoulos N, Hamilton G, Middleton MS, Martins VF, Gamst AC, Sappenfield R, Grunvald E, Funk LM, Jacobsen GR, Lidor AO, Goodman JA, Khoury SB, Sirlin CB, Reeder SB. Comparative Precision of 3D MRE and 2D MRE for Measurement of Liver Stiffness in Adults with Severe Obesity. Radiology. 2026 May;319(2):e253243. doi: 10.1148/radiol.253243.
Related trials for Non-Alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
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.
Scott Reeder, MD, PhD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease and Non-alcoholic Steatohepatitis, run by University of Wisconsin, Madison at 2 sites 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 5 inclusion and 8 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Optimization of MRE for 2 dimensional and 3 dimensional methods (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03674528, which also lists 1 linked publication.
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 19 Sep 2024.