Viewing Study NCT00401336



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Last Modification Date: 2024-10-26 @ 9:29 AM
Study NCT ID: NCT00401336
Status: COMPLETED
Last Update Posted: 2023-05-24
First Post: 2006-11-17

Brief Title: Quantification of Liver Iron Overload and Steatosis Using Magnetic Resonance Imaging
Sponsor: Rennes University Hospital
Organization: Rennes University Hospital

Study Overview

Official Title: Quantification of Liver Iron Overload and Steatosis Using a New Magnetic Resonance Imaging Multiecho Gradient-echo Sequence
Status: COMPLETED
Status Verified Date: 2023-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SURFER
Brief Summary: Iron excess is increasingly regarded as an important cofactor in the morbidity attributed to many disorders Assessment of body iron stores by measurement of serum ferritin concentrations has poor specificity and the most reliable method is histological or biochemical assessment from a liver biopsy Because liver biopsy is an invasive procedure imaging methods have been developed to detect and quantify hepatic iron content The aim of the study is to use a simplified magnetic resonance imaging MRI technique to quantify simultaneously iron and fat contents in the liver and to compare the results to the quantification obtained biochemically
Detailed Description: Iron excess is increasingly regarded as an important cofactor in the morbidity attributed to many disorders Assessment of body iron stores by measurement of serum ferritin concentrations has poor specificity and the most reliable method is histological or biochemical assessment from a liver biopsy Because liver biopsy is an invasive procedure imaging methods have been developed to detect and quantify hepatic iron content

The aim of the study is to use a simplified magnetic resonance imaging technique to quantify simultaneously iron and fat contents in the liver and to compare the results to the quantification obtained biochemically

Patients who need a liver biopsy will be proposed to be enrolled in the study A magnetic resonance MR study will be performed using breath-hold gradient echo sequences with a single echo and a new multiple-echo gradient-echo sequence Liver and muscle MR signal will be quantitatively determined and compared to biochemical assessment of liver iron concentration and steatosis quantification

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CIC0203044 None None None
PHRC04-08 None None None