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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 : November 4, 2020
Sponsor:
Collaborator:
Siemens Corporation, Corporate Technology
Information provided by (Responsible Party):
Holden H. Wu, PhD, University of California, Los Angeles

Tracking Information
First Submitted Date May 18, 2017
First Posted Date May 22, 2017
Last Update Posted Date November 4, 2020
Actual Study Start Date May 24, 2017
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 19, 2017)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Liver Fat and Iron Quantification MRI
Official Title Free-Breathing Liver Fat and Iron Quantification Using 3D Stack-of-Radial MRI
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Liver Diseases
Intervention 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
Study Groups/Cohorts
  • Healthy Subjects
    Healthy volunteers will undergo 60 minute non-contrast enhanced Magnetic Resonance Imaging (MRI) of the abdomen using novel imaging sequences.
    Intervention: 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.
    Intervention: Diagnostic Test: Magnetic Resonance Imaging (MRI)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 18, 2019)
65
Original Estimated Enrollment
 (submitted: May 19, 2017)
30
Estimated Study Completion Date December 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Healthy Volunteers:

    • Healthy subjects 18 years or older
  2. 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:

  1. Healthy Volunteers:

    • Age less than 18 years
    • Subject with the following devices/implants/conditions will be excluded:

      1. cardiac pacemakers
      2. defibrillators
      3. cochlear implants
      4. intraocular metallic foreign bodies
      5. intracranial aneurysm clips
      6. 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.
  2. Clinical Patients:

    • Age less than 18 years
    • Subject with the following devices/implants/conditions will be excluded:

      1. cardiac pacemakers
      2. defibrillators
      3. cochlear implants
      4. intraocular metallic foreign bodies
      5. intracranial aneurysm clips
      6. 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Tammy L Floore, BSN 310-794-9202 tfloore@mednet.ucla.edu
Contact: Saima Chaabane, PhD 310-794-8995 schaabane@mednet.ucla.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03162302
Other Study ID Numbers 17-000276
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Holden H. Wu, PhD, University of California, Los Angeles
Study Sponsor University of California, Los Angeles
Collaborators Siemens Corporation, Corporate Technology
Investigators
Principal Investigator: Holden H Wu, PhD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date November 2020