Liver Fat and Iron Quantification MRI

NCT03162302 | Completed

• 1 other identifier: 17-000276
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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 1.5 Tesla and 3.0 Tesla MRI scanners with or without the use of an MRI contrast agent.

Conditions

Liver Diseases

Keywords

MRI; magnetic resonance imaging; fat quantification; iron quantification

Outcome Measures

Primary Outcomes (2)

• 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

  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

  2 years

Study Arms (2)

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)

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)

Interventions

Magnetic Resonance Imaging (MRI) DIAGNOSTIC_TEST

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.

Also known as: MR

Clinical Patients; Healthy Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Healthy Volunteers:
• 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"). 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Siemens Corporation, Corporate Technology: collaborator

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Holden H Wu, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-in-Residence

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 22, 2017
• Study Start: May 24, 2017
• Primary Completion: May 3, 2021
• Study Completion: May 3, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)