MRI to Measure Liver Fat Content
Primary Purpose
Fatty Liver, Hepatitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diagnostic Radiology: 1H-MRS of the liver
Sponsored by
About this trial
This is an interventional diagnostic trial for Fatty Liver focused on measuring 1H-Magnetic Resonance Spectroscopy, Hepatic Steatosis, Liver Fat, Liver Biopsy, Liver, Hepatitis, Fatty Liver
Eligibility Criteria
- INCLUSION CRITERIA:
Age 18+, male or female
Planned liver biopsy or liver biopsy within the past month with pathology samples available to be read at NIH CC
EXCLUSION CRITERIA:
Known current pregnancy or pregnancy within 6 months
Contraindications to MRI
Subject is deemed unable to comply with requirements of study participation
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Outcomes
Primary Outcome Measures
Validate 1H-Magnetic Resonance Spectroscopy to assess hepatic steatosis
Secondary Outcome Measures
Full Information
NCT ID
NCT00594412
First Posted
January 3, 2008
Last Updated
June 30, 2017
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00594412
Brief Title
MRI to Measure Liver Fat Content
Official Title
Validation of (1)H-Magnetic Resonance Spectroscopy for Quantification of Hepatic Triglyceride Content
Study Type
Interventional
2. Study Status
Record Verification Date
June 15, 2011
Overall Recruitment Status
Completed
Study Start Date
December 20, 2007 (undefined)
Primary Completion Date
July 1, 2010 (Actual)
Study Completion Date
June 15, 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief Summary
This study will determine whether a magnetic resonance imaging (MRI) test of the liver can accurately measure the amount of fat in the liver compared to the results of a liver biopsy.
People 18 years of age and older who are scheduled to have or who have already had a liver biopsy as part of their medical care within 1 month of enrollment in this study may be eligible to participate.
Participants undergo an MRI. For this procedure, the subject lies still on a table that slides into a narrow metal cylinder (the MRI scanner) for 30 to 60 minutes. A special pad or tube is placed around the abdomen to improve the image of the liver obtained. Earplugs are placed in the ears to muffle loud thumping and knocking sounds that occur with the electrical switching of the magnetic field. The findings of the MRI are compared with those of the liver biopsy.
Detailed Description
Percutaneous liver biopsy remains the gold standard test to evaluate hepatic fat content, fibrosis and cirrhosis, but there is growing interest in the application of magnetic resonance imaging (MRI) techniques such as (1)H-Magnetic Resonance Spectroscopy ((1)H-MRS) as a non-invasive approach to quantify these characteristics. The ability to accurately quantify hepatic metabolites, such as intrahepatic lipid, has important implications for clinical evaluation and management of patients with liver related diseases and may obviate the need for liver biopsies in a number of clinical settings. The current proposal is designed to develop and validate hepatic (1)H-MRS capabilities at the NIH Clinical Center and to use this technique in a subsequent study to estimate the prevalence of hepatic steatosis among persons living with HIV/AIDS. In the present study we propose to complete MRI with (1)H-MRS in 70 adults who will be undergoing percutaneous liver biopsy in order to establish the ability of (1)H-MRS to accurately assess hepatic fat content compared to histopathological scoring.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver, Hepatitis
Keywords
1H-Magnetic Resonance Spectroscopy, Hepatic Steatosis, Liver Fat, Liver Biopsy, Liver, Hepatitis, Fatty Liver
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Diagnostic Radiology: 1H-MRS of the liver
Primary Outcome Measure Information:
Title
Validate 1H-Magnetic Resonance Spectroscopy to assess hepatic steatosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Age 18+, male or female
Planned liver biopsy or liver biopsy within the past month with pathology samples available to be read at NIH CC
EXCLUSION CRITERIA:
Known current pregnancy or pregnancy within 6 months
Contraindications to MRI
Subject is deemed unable to comply with requirements of study participation
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12135038
Citation
Nakao K, Nakata K, Ohtsubo N, Maeda M, Moriuchi T, Ichikawa T, Hamasaki K, Kato Y, Eguchi K, Yukawa K, Ishii N. Association between nonalcoholic fatty liver, markers of obesity, and serum leptin level in young adults. Am J Gastroenterol. 2002 Jul;97(7):1796-801. doi: 10.1111/j.1572-0241.2002.05846.x.
Results Reference
background
PubMed Identifier
8963350
Citation
Banerji MA, Buckley MC, Chaiken RL, Gordon D, Lebovitz HE, Kral JG. Liver fat, serum triglycerides and visceral adipose tissue in insulin-sensitive and insulin-resistant black men with NIDDM. Int J Obes Relat Metab Disord. 1995 Dec;19(12):846-50.
Results Reference
background
PubMed Identifier
11704429
Citation
Sabir N, Sermez Y, Kazil S, Zencir M. Correlation of abdominal fat accumulation and liver steatosis: importance of ultrasonographic and anthropometric measurements. Eur J Ultrasound. 2001 Dec;14(2-3):121-8. doi: 10.1016/s0929-8266(01)00153-7.
Results Reference
background
PubMed Identifier
22733887
Citation
Georgoff P, Thomasson D, Louie A, Fleischman E, Dutcher L, Mani H, Kottilil S, Morse C, Dodd L, Kleiner D, Hadigan C. Hydrogen-1 MR spectroscopy for measurement and diagnosis of hepatic steatosis. AJR Am J Roentgenol. 2012 Jul;199(1):2-7. doi: 10.2214/AJR.11.7384.
Results Reference
derived
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MRI to Measure Liver Fat Content
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