N/A
N=142
Massive Iron Deposit Assessment
Iron Overload · Excessive Body Iron Burden
Bottom Line
View on ClinicalTrials.gov: NCT01572922 ↗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
| Outcome | Result | p-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.
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.