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Massive Iron Deposit Assessment


N/A
N/A
N/A
Open (Enrolling)
Both
Iron Overload, Excessive Body Iron Burden

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Trial Information

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.

Primary Objective:

- 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
overload.

Secondary Objectives:

- 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.

Inclusion Criteria


Inclusion Criteria - Patients:

- History of 12 or more lifetime erythrocyte transfusions, AND

- Need for liver iron content assessment (by MRI or liver biopsy)

Inclusion Criteria - Healthy Volunteers:

- Age 18 years or older, AND

- Willingness to undergo MRI testing for investigation and implementation of the
R2*-UTE technique.

Exclusion Criteria - Patients:

- Presence of certain MR-unsafe foreign material in the body, or other conditions that
make the research participant ineligible for an MRI scan per St. Jude policies.

- Any condition or chronic illness that in the opinion of the PIs makes participation
on study ill-advised.

Exclusion Criteria - Healthy Volunteers:

- History of blood transfusions in the lifetime.

- Known history of hereditary hemochromatosis

- Presence of certain foreign, MR-unsafe material in the body, or other conditions that
make the volunteer ineligible for an MRI scan per St. Jude policies.

- Any condition or chronic illness that in the opinion of the PIs makes participation
on study ill-advised.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Hepatic iron content in the liver using using liver biopsy

Outcome Description:

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

Outcome Time Frame:

up to 30 days after MRI

Safety Issue:

No

Principal Investigator

Jane Hankins, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

MIDAS

NCT ID:

NCT01572922

Start Date:

April 2012

Completion Date:

April 2017

Related Keywords:

  • Iron Overload
  • Excessive Body Iron Burden
  • Sickle cell disease
  • Thalassemia
  • Hemochromatosis
  • Cancer
  • Iron Overload

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794