MRI to Measure Liver Fat Content | NCT00594412

Studies
MRI to Measure Liver Fat Content

NCT00594412

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Completed

Last Update Posted

Jul 2, 2017Actual

Enrollment

53Actual

Phase

Not Applicable

Conditions

Fatty Liver
Hepatitis

Interventions

Diagnostic Radiology: 1H-MRS of the liver

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
08-I-0034

Status Module

Record Verification Date

Jun 15, 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2007

Primary Completion Date

Jul 1, 2010Actual

Completion Date

Jun 15, 2011Actual

First Submitted Date

Jan 3, 2008

First Submission Date that Met QC Criteria

Jan 3, 2008

First Posted Date

Jan 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2017

Last Update Posted Date

Jul 2, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)NIH

Collaborators

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic Radiology: 1H-MRS of the liver	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validate 1H-Magnetic Resonance Spectroscopy to assess hepatic steatosis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institutes of Health Clinical Center, 9000 Rockville Pike		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12135038	Background	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.
8963350	Background

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
D005234	Fatty Liver
D006505	Hepatitis