Fatty Liver Clinical Trial
Official title:
Validation of (1)H-Magnetic Resonance Spectroscopy for Quantification of Hepatic Triglyceride Content
Verified date | June 15, 2011 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 53 |
Est. completion date | June 15, 2011 |
Est. primary completion date | July 1, 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- 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 |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Validate 1H-Magnetic Resonance Spectroscopy to assess hepatic steatosis |
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