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NCT01241357 · ClinicalTrials.gov registry record
High-Tc Susceptometer to Monitor Transfusional Iron Overload
A clinical trial, sponsored by Columbia University.
- Completed
- Registry status
- 99
- Enrollment target
NCT01241357: Completed study, sponsored by Columbia University.
NCT01241357 is a clinical trial that has completed, run by Columbia University. The registered enrollment target is 99 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01241357 has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- 99 participants
- Enrollment target
Study Summary
The proposed research project will continue the application and development of a new method (biomagnetic susceptometry) that measures magnetic fields to determine how much iron is in the liver. The amount of iron in the liver is the best indicator of the amount of iron in the whole body. Measuring the amount of iron in the body is important because either too much (iron overload) or too little iron (iron deficiency) can be harmful. At present, the most reliable way to measure the amount of iron in the liver is to remove a sample of the liver by biopsy, either by surgery or by using a needle which pierces the skin and liver. Iron stored in the liver can be magnetized to a small degree when placed in a magnetic field. In patients with iron overload, the investigators previous studies have shown that magnetic measurements of liver iron in patients with iron overload are quantitatively equivalent to biochemical determinations on tissue obtained by biopsy. In the past the investigators have developed a device to measure the amount of magnetization, which was called a SQUID (Superconducting QUantum Interference Device) susceptometer. This device was validated and in use for over 20 years. The safety, ease, rapidity and comfort of magnetic measurements make frequent, serial studies technically feasible and practically acceptable to patients. The investigators have now developed a new susceptometer, which uses very similar technology to the SQUID, but the investigators believe is more accurate and precise. This study aims to validate this new instrument. The investigators will do prospective, serial studies of the diagnosis and management of patients with iron overload, including thalassemia major (Cooley's anemia), sickle cell disease, aplastic anemia, myelodysplasia, hereditary hemochromatosis, and other disorders. Funding Source - FDA OOPD.
Primary Outcome
The primary study analysis will be a comparison of the results of measurements of the hepatic storage iron concentration by biomagnetic susceptometry with the results of biochemical analysis of the storage iron concentration in liver tissue.
Interventions
- DEVICE Hepatic biomagnetic susceptibility measurement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2011-03 |
| Est. Completion | 2016-05 |
What the finished NCT01241357 record still lists
NCT01241357 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 99 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Hepatic biomagnetic susceptibility measurement is the first listed.
NCT01241357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01241357 about?
NCT01241357 is a clinical study titled "High-Tc Susceptometer to Monitor Transfusional Iron Overload". The proposed research project will continue the application and development of a new method (biomagnetic susceptometry) that measures magnetic fields to determine how much iron is in the liver. The amount of iron in the liver is the best indicator of the amount of iron in the whole body. Measuring t...
What is the current status of trial NCT01241357?
This trial is currently completed. The enrollment target is 99 participants. The study started on 2011-03. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01241357?
The interventions under investigation include: Hepatic biomagnetic susceptibility measurement (DEVICE).
Who is sponsoring clinical trial NCT01241357?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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