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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00675038
First Posted: May 8, 2008
Last Update Posted: September 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
  Purpose

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.


Condition Intervention
Hematological Diseases Procedure: Liver Biopsy and MRI T2* MRI

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Enrollment: 52
Study Start Date: October 2005
Study Completion Date: June 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Clinic
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
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): NCT00675038


Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Jane Hankins, MD St. Jude Children's Research Hospital
  More Information