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

NCT00675038 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2011-09-15

No results posted yet for this study

Summary

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.

Conditions

  • Hematological Diseases

Interventions

PROCEDURE

Liver Biopsy and MRI T2* MRI

Evaluation of iron overload with liver biopsy vs. MRI T2\* MRI

Sponsors & Collaborators

Principal Investigators

  • Jane Hankins, MD · St. Jude Children's Research Hospital

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2007-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00675038 on ClinicalTrials.gov