High-Tc Susceptometer to Monitor Transfusional Iron Overload
|ClinicalTrials.gov Identifier: NCT01241357|
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : September 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Transfusional Iron Overload Thalassemia Major Sickle Cell Disease Myelodysplastic Syndromes Aplastic Anemia||Device: Hepatic biomagnetic susceptibility measurement||Phase 2|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||99 participants|
|Official Title:||High-Tc Susceptometer to Monitor Transfusional Iron Overload (NSR Device)|
|Study Start Date :||March 2011|
|Primary Completion Date :||October 2015|
|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.
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|