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Trial record 2 of 5220 for:    QUANTIFY

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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
Fatty liver in the obese is a common finding; some cases develop steato-hepatosis which in the long-term can lead to liver cirrhosis. The effect of bariatric surgery on fat distribution in the liver has so far been studied with liver biopsies and single voxel MR techniques. With this trial investigators present a new, whole organ MR-quantification of liver fat and describe changes after bariatric surgery in visceral and subcutaneous fat.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Obesity Other: MR Abdomen Not Applicable

Detailed Description:

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
Allocation: Non-Randomized
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Liver fat quantification [ Time Frame: within 3, 6 and 12 months of surgery ]
    change in fat quantification; measurement of fat rate in the organ


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • morbidly obese patients with BMI over 35, scheduled for bariatric surgery (either sleeve gastrectomy or gastric bypass)

Exclusion Criteria:

  • Smoking
  • substance abuse
  • Diabetes
  • history of gastrointestinal disorders
  • pace-maker
  • claustrophobia

Information from the National Library of Medicine

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


Locations
Switzerland
University Hospital
Basel, Switzerland, CH-4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christoph Beglinger, MD University Hospital, Basel, Switzerland

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02682173     History of Changes
Other Study ID Numbers: MRI Fat quantification
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases