High-Tc Susceptometer to Monitor Transfusional Iron Overload
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|ClinicalTrials.gov Identifier: NCT01241357|
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : September 21, 2016
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|Condition or disease||Intervention/treatment|
|Transfusional Iron Overload Thalassemia Major Sickle Cell Disease Myelodysplastic Syndromes Aplastic Anemia||Device: Hepatic biomagnetic susceptibility measurement|
|Study Type :||Observational|
|Actual Enrollment :||99 participants|
|Official Title:||High-Tc Susceptometer to Monitor Transfusional Iron Overload (NSR Device)|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||May 2016|
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.
- Hepatic non-heme iron concentration determined by biomagnetic susceptometry [ Time Frame: 2 years ]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 ]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.
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|Ages Eligible for Study:||5 Years to 80 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241357
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Gary M. Brittenham, M.D.||Columbia University|
|Responsible Party:||Gary M Brittenham, MD, James A. Wolff Professor of Pediatrics, Columbia University|
|Other Study ID Numbers:||
R01FD003702 ( U.S. FDA Grant/Contract )
|First Posted:||November 16, 2010 Key Record Dates|
|Last Update Posted:||September 21, 2016|
|Last Verified:||September 2016|
Hepatic iron concentration
Anemia, Sickle Cell
Bone Marrow Diseases
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Bone Marrow Failure Disorders
Iron Metabolism Disorders