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High-Tc Susceptometer to Monitor Transfusional Iron Overload (NSR Device)

This study is currently Recruiting

September 2011 By Columbia University

First Recieved on November 12, 2010

Last Updated on September 27, 2011

Sponsor: Columbia University
Collaborators: Food and Drug Administration (FDA)
Information provided by: Columbia University
Identifier: NCT01241357

Purpose

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.

Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Eligibility

Ages Eligible for Study:5 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria: - being an adult male, nonpregnant female or child who is scheduled for liver transplantation, has transfusional iron overload or is healthy with no known disorder affecting body iron stores, - being of sufficient size for the susceptometer (about 15 kg body weight), - being able to lie quietly during the measurement procedure (about 5 to 10 minutes), - being either able to give fully informed consent or, if a minor, with a parent or legal guardian who is able to give fully informed consent for participation of the minor. Exclusion Criteria: - any form of magnetic contamination or electrical device which cannot be removed for the magnetic measurement procedure, including jewelry, pacemakers, artificial joints, metal staples, indwelling catheters with metallic components, dental braces or other magnetic objects; - obesity, ascites or other conditions in which the liver to surface distance exceeds 25 mm; - pregnancy, treatment for mental illness, imprisonment, institutionalization, or any condition that impairs ability to provide fully informed consent.

Investigators

  • Investigator: Gary M. Brittenham, M.D. - Principal Investigator - Columbia University

Locations

  • Columbia University Medical Center

    New York, New York 10032 United States

Conditions related to this trial:

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