Clinical Trial: Massive Iron Deposit Assessment

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: Massive Iron Deposit Assessment

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: 235 (200 patients, 35 healthy volunteers)

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 200. It is estimated that 41 of these patients will have clinical indication for liver biopsy.

Volunteer purpose: To test the UTE MRI to ensure it runs correctly before testing in patients, collect data of normal values of iron in the liver in people without iron overload using the UTE MRI and to compare the current MRI (GRE) with the UTE. The UTE MRI will give an accurate value of liver iron in patients with large iron deposits in the liver, therefore providing an accurate means to diagnose, monitor, and provide treatments for participants. This