Skip to main content
OpenTrials
Completed

NCT Number: NCT03162302

Liver Fat and Iron Quantification 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California Los Angeles

Los Angeles, California, 90024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

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.

Other names: MR

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Siemens Corporation, Corporate Technology

Registry information

Official study title

Free-Breathing Liver Fat and Iron Quantification Using 3D Stack-of-Radial MRI

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 22, 2017
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.