Massive Iron Deposit Assessment
The MIDAS study is a prospective and non-therapeutic study that will test a new MRI
technique for the assessment of iron overload in the liver: the newly developed ultra short
echo time (UTE), R2*-UTE. The R2*-UTE technique, developed by St. Jude investigators from
the Department of Radiological Sciences, will be first tested in healthy volunteers for
feasibility and implementation of the technique. The technique will then be tested in
research participants, who will have both the R2*-GRE and the R2*-UTE techniques performed,
in addition to a liver biopsy for liver iron quantitation if clinically indicated.
Quantitation of liver tissue iron will be done at Mayo Clinic Laboratory in Rochester,
Minnesota. Healthy volunteers will not have a liver biopsy performed but only the two types
of R2*-MRI techniques will be performed and compared.
- To test the association of hepatic iron content (HIC) measured with the newly developed
1.5T R2*-UTE technique and HIC quantified by liver biopsy in subjects with iron
- To explore the relationship between 1.5T R2*-UTE and 1.5T R2*-GRE measurements in
healthy volunteers and in subjects with iron overload.
- To explore the relationship between 1.5T R2*-UTE measurements with iron studies (serum
iron and transferrin saturation) in subjects with iron overload.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Hepatic iron content in the liver using using liver biopsy
The liver biopsies will be obtained as indicated by good clinical management practice, and it is expected that most research participants who will receive the liver biopsy will have an inconclusive result by the R2*-GRE method. The iron quantification assessed in liver biopsies will be correlated with the R2*-UTE signals. If the correlation is sufficiently high, then a statistical model relating HIC by R2*-UTE and liver biopsy values will be established, as was done for R2*-GRE.32
up to 30 days after MRI
Jane Hankins, MD, MS
St. Jude Children's Research Hospital
United States: Institutional Review Board
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|