Magnetic Resonance Imaging (MRI) Fat Quantification of the Liver
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|ClinicalTrials.gov Identifier: NCT02682173|
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : July 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-alcoholic Fatty Liver Disease Obesity||Other: MR Abdomen||Not Applicable|
Currently, liver biopsy is still regarded as the gold-standard in the diagnosis of non-alcoholic fatty liver disease and monitoring of progression. However, accuracy of diagnosis is not perfect with a certain risk of sampling error depending on biopsy quality and a more or less homogeneous distribution of liver tissue alterations. Complications are rare; however, the method is invasive and carries the risk of bleeding. Therefore, non-invasive methods (such as serum biomarkers or imaging techniques) are sought for accurate diagnosis and safe monitoring of disease progression. Unidimensional transient elastography (TE; FibroScan®) is a non-invasive technique, which can be a helpful tool here: however, accuracy of diagnosis is depending on the stage of fibrosis and lower grades of fibrosis (stage 1 and 2) are difficult to assess. Moreover, in obese patients this method cannot be applied.
In recent years, the development of fat-water magnetic resonance imaging has enabled non-invasive assessment of fat and water content in tissues. In addition, modern MRI devices allow brief breath holding, which reduces motion artifacts and provides us with excellent data and therefore MRI has become an important tool for fat quantification.
Up to date only a few studies have focused on fat quantification before and after bariatric surgery: patients treated with laparoscopic gastric banding (a purely restrictive procedure) and patients undergoing metabolic surgery such as sleeve gastrectomy and gastric bypass have been examined pre- and postoperatively by means of MRI fat quantification. However, in these studies single voxel spectroscopy was used. In contrast, in this current trial investigators aim to assess full organ volume, which hopefully will provide more accurate data.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||MRI Fat Quantification of the Liver, Subcutaneous and Visceral Fatty Tissue in Patients Before and After Bariatric Surgery|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
Active Comparator: Laparoscopic gastric bypass
MR Abdomen in morbidly obese patients receiving gastric bypass
Other: MR Abdomen
Active Comparator: Laparoscopic sleeve gastrectomy
MR Abdomen morbidly obese patients receiving sleeve gastrectomy
Other: MR Abdomen
- Liver fat quantification [ Time Frame: within 3, 6 and 12 months of surgery ]change in fat quantification; measurement of fat rate in the organ
- Visceral fat quantification [ Time Frame: within 3, 6 and 12 months of surgery ]change in fat quantification visceral; 2-point Dixon technique for volumetric fat imaging
- Subcutaneous fat quantification [ Time Frame: within 3, 6 and 12 months of surgery ]change in fat quantification subcutaneous; 2-point Dixon technique for volumetric fat imaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682173
|Basel, Switzerland, CH-4031|
|Principal Investigator:||Christoph Beglinger, MD||University Hospital, Basel, Switzerland|