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NCT01572922 · ClinicalTrials.gov registry record · NA
Massive Iron Deposit Assessment
A NA study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- NA
- Development phase
- 142
- Enrollment target
NCT01572922: Completed NA study, sponsored by St. Jude Children's Research Hospital.
NCT01572922 is a NA study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 142 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01572922, a NA study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 142 participants
- Enrollment target
Study 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.
Primary Outcome
Hepatic iron content in the liver using liver biopsy
Interventions
- PROCEDURE Liver biopsy
- DEVICE R2*-UTE
- DEVICE R2*-GRE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2012-06-11 |
| Est. Completion | 2018-02-28 |
| Phase | NA |
What the finished NCT01572922 record still lists
NCT01572922 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Liver biopsy is the first listed.
NCT01572922 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01572922 about?
NCT01572922 is a clinical study titled "Massive Iron Deposit Assessment". 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 accumulat...
What is the current status of trial NCT01572922?
This trial is currently completed. It is a NA study. The enrollment target is 142 participants. The study started on 2012-06-11. Estimated completion is 2018-02-28.
What interventions are being tested in trial NCT01572922?
The interventions under investigation include: Liver biopsy (PROCEDURE), R2*-UTE (DEVICE), R2*-GRE (DEVICE).
Who is sponsoring clinical trial NCT01572922?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01572922's enrollment target sits among peer trials
142 711th of 2000 higher than 1,289 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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