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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 is a NA study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 142 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01572922
The ClinicalTrials.gov registry entry for NCT01572922 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Liver biopsy is the first listed.
NCT01572922 reports 0 study locations.
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.
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