Massive Iron Deposit Assessment
Completed · Not applicable
Conditions studied: Iron Overload, Excessive Body Iron Burden
In brief
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.
Key facts
- Study ID
- NCT01572922
- Run by
- St. Jude Children's Research Hospital
- People needed
- 142
- Starts
- 2012-06-11
- Expected to finish
- 2018-02-28
- Last updated by the study team
- 2019-06-11
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- History of 12 or more lifetime erythrocyte transfusions, AND
- Need for liver iron content assessment (by MRI or liver biopsy)
You may not qualify if…
- 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.
Where it is running
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.