Pilot Study of Non-Invasive Assessment of Hepatic And Myocardial Iron Through T2* Magnet Resonance Imaging (MRI) In Patients With Iron Overload

Completed

Conditions studied: Hematological Diseases

In brief

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.

Key facts

Study ID

NCT00675038

Run by

St. Jude Children's Research Hospital

People needed

52

Starts

2005-10-01

Expected to finish

2008-06-01

Last updated by the study team

2011-09-15

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is greater than or equal to 7 years of age
• Participant needs a liver biopsy for monitoring iron overload
• Participant is willing to have magnetic resonance testing

You may not qualify if…

• Patients with surgical clips placed in the United States after August 15th 1996 will be eligible to participate on the study.
• Contraindication to performing magnetic resonance testing, such as the presence of ferromagnetic material in the body
• Cannot tolerate an MRI without sedation or anesthesia.

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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