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N/A N=142 Diagnostic

Massive Iron Deposit Assessment

Iron Overload · Excessive Body Iron Burden

Enrolled (actual)
142
Serious AEs
0.7%
Results posted
May 2019
Primary outcome: Primary: Hepatic Iron Content in the Liver Using Liver Biopsy — 19.8 mcg

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
R2*-UTE (Device); R2*-GRE (Device); Liver biopsy (Procedure)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
St. Jude Children's Research Hospital
Primary completion
Feb 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Hepatic Iron Content in the Liver Using Liver Biopsy
19.8
PRIMARY
MRI-derived R2* Values Using 1.5T UTE Technique
864.4
SECONDARY
MRI-derived R2* Using 1.5T GRE Technique
333.8
SECONDARY
MRI Derived R2* Using 1.5T UTE Technique
319.2
SECONDARY
R2* Using 1.5T UTE Technique for Patients With Serum Iron and Transferrin Saturation Measurements
340.8
SECONDARY
Serum Iron Measurements Compared With 1.5T R2* UTE
156.5
SECONDARY
Transferrin Saturation Measurements
71

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01572922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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