High-Tc Susceptometer to Monitor Transfusional Iron Overload
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Transfusional Iron Overload Thalassemia Major Sickle Cell Disease Myelodysplastic Syndromes Aplastic Anemia |
Device: Hepatic biomagnetic susceptibility measurement |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Bio-equivalence Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | High-Tc Susceptometer to Monitor Transfusional Iron Overload (NSR Device) |
- Hepatic non-heme iron concentration determined by biomagnetic susceptometry [ Time Frame: 2 years ] [ Designated as safety issue: No ]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.
- Serum ferritin concentration [ Time Frame: 2 years ] [ Designated as safety issue: No ]A secondary study analysis will be a comparison of the results of measurements of the hepatic storage iron concentration by biomagnetic susceptometry with the results of measurements of the serum ferritin concentration.
| Estimated Enrollment: | 190 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Observation only
This study has a single arm and no intervention.
|
Device: Hepatic biomagnetic susceptibility measurement
Subjects will first have an ultrasound study to determine the location of the liver and measure the distance from skin surface to the liver. Subjects will then be examined with the high Tc susceptometer to determine the amount of iron in the liver. The entire procedure will usually take one-half hour or less.
Other Names:
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 5 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Genia Billote, R.N., M.P.H. | 212-342-0262 | gbb2101@columbia.edu |
| Contact: Sujit Sheth, M.D. | 212-305-8495 | ss125@columbia.edu |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Genia Billote, R.N., M.P.H. 212-342-0262 gbb2101@columbia.edu | |
| Contact: Sujit Sheth, M.D. 212-305-8495 ss125@columbia.edu | |
| Principal Investigator: Gary M. Brittenham, M.D. | |
| Sub-Investigator: Sujit Sheth, M.D. | |
| Principal Investigator: | Gary M. Brittenham, M.D. | Columbia University |
More Information
Publications:
| Responsible Party: | Gary M Brittenham, MD, James A. Wolff Professor of Pediatrics, Columbia University |
| ClinicalTrials.gov Identifier: | NCT01241357 History of Changes |
| Other Study ID Numbers: | AAAE5051, R01FD003702 |
| Study First Received: | November 12, 2010 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Columbia University:
|
Iron Iron overload Hepatic iron concentration |
High-temperature superconductivity Magnetic susceptibility Susceptometer |
Additional relevant MeSH terms:
|
Iron Overload Hematologic Diseases Bone Marrow Diseases Genetic Diseases, Inborn Precancerous Conditions Iron Metabolism Disorders Metabolic Diseases Iron Anemia Anemia, Aplastic Beta-Thalassemia Anemia, Sickle Cell |
Myelodysplastic Syndromes Preleukemia Thalassemia Anemia, Hemolytic, Congenital Anemia, Hemolytic Hemoglobinopathies Neoplasms Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013