MIDAS: Massive Iron Overload Assessment

Category:

Supportive Hematological Disorders Studies

Diseases Treated:

Iron overload 

Eligibility Overview:

This is a non-therapeutic clinical trial that is only open to St. Jude patients.

  • Participant has a history of 12 or more lifetime erythrocyte transfusions.
  • Participant has a need for liver iron content assessment.
  • No contra-indication to having an MRI exam, such as the presence of metal in the body.

Description

This is a study of iron overload, a condition when too much iron is present in a person’s body as a result of too many blood transfusions he/she received. Too much iron in the body is a problem because iron collects in vital organs such as the heart and the liver and may cause these organs not to work right. The iron in the body needs to be measured so the physician can decide if it is time to begin a treatment to get rid of the iron from the patient body. Researchers at St. Jude Children’s Research Hospital developed a type of MRI to measure iron in the liver of people with iron overload called R2*-GRE.

However, the R2*-GRE MRI cannot measure the iron in the liver of people with very high amounts of iron. In these cases, a liver biopsy is the only way to measure the amount of iron. A liver biopsy is a procedure that takes a piece of the liver out of the body by using a needle. A liver biopsy is a good way to determine how much iron a patient has in his/her body, but it has risks such as pain, bleeding and infection. St. Jude investigators have developed a newer type of MRI of the liver that could possibly measure iron even in people with very high amounts of iron in the liver. This new type of MRI is called ultra-short echo time (UTE) MRI. The investigators are doing this study to compare the results of a patient’s UTE MRI with the results of the same patient’s liver biopsy, when the patient has very high iron in the body.

Objectives

To determine if a new MRI, (UTE) MRI, can measure the amount of iron in the liver of people with large amount of iron and compare the results with the same patient’s liver biopsy.

In volunteers: To test the UTE MRI to make sure it runs correctly before testing in patients, collect data of normal values of iron in the liver in people without iron overload using the UTE MRI and to compare the current MRI (GRE) with the UTE.

In patients: To learn if the new type of MRI, ultra-short echo time (UTE) MRI, can measure with precision the amount of iron in the liver of people with extreme amounts of iron and to compare the results of the new UTE MRI with that of a liver biopsy in patients with extremely high amounts of iron in the liver.

The UTE MRI will give an accurate value of liver iron in patients with large liver iron deposits in the liver, therefore providing an accurate means to diagnose, monitor and provide treatments for participants.

Eligibility

For volunteers

  • Willingness to undergo MRI testing for investigation and implementation of the R2*-UTE technique.
  • Any condition or chronic illness that in the opinion of the investigators makes participation on study ill-advised.
  • No contra-indication to having an MRI exam, such as the presence of metal in the body.

For patients

  • Participant has a history of 12 or more lifetime erythrocyte transfusions.
  • Participant has a need for liver iron content assessment.
  • No contra-indication to having an MRI exam, such as the presence of metal in the body.
  • Does not have any condition or chronic illness that in the opinion of the PIs makes participation on study ill-advised.

Principal Investigator

Jane Hankins, MD, MS

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

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