Pilot Study of Non-Invasive Assessment of Hepatic And Myocardial Iron Through T2* Magnet Resonance Imaging (MRI) In Patients With Iron Overload
Many hematological disorders are treated by giving red blood cells. Over a long period of time iron from the red blood cell will accumulate in the tissues of the heart, liver, and endocrine glands. This condition is referred to as iron overload and may become life threatening due to the effects of the iron on these tissues. The normal method for evaluation of iron overload is a liver biopsy. This procedure is invasive and has potential risks, such as bleeding and infection.
It is very desirable to establish a method for assessing iron overload which is not invasive. New magnet resonance imaging (MRI) relaxation techniques (T2*MRI) can be used to indirectly assess the liver iron content and iron in the heart. Results of T2*MRIs show excellent correlation with liver iron content and heart function. The use of this method of assessment will minimize the risk and inconvenience of liver biopsy and possibly allow more frequent evaluations for iron overload, thus better treatment for these patients.
Participants in this study will undergo both liver biopsy for liver iron content and T2* MRI of the liver and the heart. Results from the procedures performed in this study will be compared, with the end result being the possible elimination of invasive procedures to diagnose iron overload.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Pilot Study of Non-Invasive Assessment of Hepatic And Myocardial Iron Through T2* MRI In Patients With Iron Overload|
|Study Start Date:||October 2005|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Study participants will be patients who are cared for by the St. Jude Hematology Division and have developed iron overload and require liver biopsy.
Procedure: Liver Biopsy and MRI T2* MRI
Evaluation of iron overload with liver biopsy vs. MRI T2* MRI
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00675038
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Jane Hankins, MD||St. Jude Children's Research Hospital|