Clinical trial NCT01572922: Massive Iron Deposit Assessment
Official title: Massive Iron Deposit Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Overload
Excessive Body Iron Burden
Keywords: Sickle cell disease
Thalassemia
Hemochromatosis
Cancer
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Regional One Health
First posted: 2012-04-06
Enrollment: 142
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hepatic Iron Content in the Liver Using Liver Biopsy
timeFrame: up to 30 days after MRI
measure: MRI-derived R2* Values Using 1.5T UTE Technique
timeFrame: Up to 30 days after MRI
Secondary outcomes:
measure: MRI-derived R2* Using 1.5T GRE Technique
timeFrame: Up to 30 days after MRI
measure: MRI Derived R2* Using 1.5T UTE Technique
timeFrame: up to 30 days after MRI
measure: R2* Using 1.5T UTE Technique for Patients With Serum Iron and Transferrin Saturation Measurements
timeFrame: Up to 30 days after MRI
measure: Serum Iron Measurements Compared With 1.5T R2* UTE
timeFrame: Up to 30 days after MRI
measure: Transferrin Saturation Measurements
timeFrame: Up to 30 days after MRI
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Jane Hankins, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: