NCT00594412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2011

Completed
Last Updated

July 2, 2017

Status Verified

June 15, 2011

Enrollment Period

2.5 years

First QC Date

January 3, 2008

Last Update Submit

June 30, 2017

Conditions

Keywords

1H-Magnetic Resonance SpectroscopyHepatic SteatosisLiver FatLiver BiopsyLiverHepatitisFatty Liver

Outcome Measures

Primary Outcomes (1)

  • Validate 1H-Magnetic Resonance Spectroscopy to assess hepatic steatosis

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known current pregnancy or pregnancy within 6 months
  • Contraindications to MRI
  • Subject is deemed unable to comply with requirements of study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

  • 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.

    PMID: 12135038BACKGROUND
  • 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.

    PMID: 8963350BACKGROUND
  • 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.

    PMID: 11704429BACKGROUND
  • 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.

MeSH Terms

Conditions

Fatty LiverHepatitis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

December 20, 2007

Primary Completion

July 1, 2010

Study Completion

June 15, 2011

Last Updated

July 2, 2017

Record last verified: 2011-06-15

Locations