Massive Iron Deposit Assessment
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/20/2019 |
| Start Date: | June 11, 2012 |
| End Date: | February 28, 2018 |
Iron overload is a severe complication of multiple blood transfusions. As the body has no
physiologic mechanism for clearing iron, repeated transfusions cause iron accumulation in
organs and lead to iron toxicity. Accurate assessment of iron overload is paramount to
quantify excessive iron accumulation and to monitor response to iron chelation therapy.
Magnetic resonance imaging (MRI) methods have been used to noninvasively measure hepatic iron
concentration (HIC). Although MRI-based measurements of transverse relaxation rates (R2 and
R2*) accurately predict biopsy-proven HICs below 15 mg Fe/g, previous studies have shown that
their precision is limited for HICs above 15 mg Fe/g and inaccurate above 25 mg Fe/g. Current
R2* gradient-echo (GRE) MR techniques fail occasionally for very high iron overloads (HIC ~
15-25 mg Fe/g) and always for massive iron overloads (HIC > 25 mg Fe/g) because R2* is so
high that the MR signal decays before it can be measured accurately.
Overall accrual: 200 patients
Purpose: To determine if a new MRI (UTE) can measure the amount of iron in the liver of
people with large amounts of iron and compare the results with the same patient's liver bx.
Estimated patient accrual is 150. It is estimated that 41 of these patients will have
clinical indication for liver biopsy.
physiologic mechanism for clearing iron, repeated transfusions cause iron accumulation in
organs and lead to iron toxicity. Accurate assessment of iron overload is paramount to
quantify excessive iron accumulation and to monitor response to iron chelation therapy.
Magnetic resonance imaging (MRI) methods have been used to noninvasively measure hepatic iron
concentration (HIC). Although MRI-based measurements of transverse relaxation rates (R2 and
R2*) accurately predict biopsy-proven HICs below 15 mg Fe/g, previous studies have shown that
their precision is limited for HICs above 15 mg Fe/g and inaccurate above 25 mg Fe/g. Current
R2* gradient-echo (GRE) MR techniques fail occasionally for very high iron overloads (HIC ~
15-25 mg Fe/g) and always for massive iron overloads (HIC > 25 mg Fe/g) because R2* is so
high that the MR signal decays before it can be measured accurately.
Overall accrual: 200 patients
Purpose: To determine if a new MRI (UTE) can measure the amount of iron in the liver of
people with large amounts of iron and compare the results with the same patient's liver bx.
Estimated patient accrual is 150. It is estimated that 41 of these patients will have
clinical indication for liver biopsy.
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.
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
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.
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.
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
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.
Inclusion Criteria
- History of 12 or more lifetime erythrocyte transfusions, AND
- Need for liver iron content assessment (by MRI or liver biopsy)
Exclusion Criteria
- 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.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Jane Hankins, MD, MS
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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