Status:
COMPLETED
High-Tc Susceptometer to Monitor Transfusional Iron Overload
Lead Sponsor:
Columbia University
Conditions:
Transfusional Iron Overload
Thalassemia Major
Eligibility:
All Genders
5-80 years
Brief 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 am...
Detailed Description
This project will validate our new high-transition-temperature (high-Tc; operating at 77°K, cooled by liquid nitrogen) superconducting magnetic susceptometer as the most clinically effective means for...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01241357
Start Date
March 1 2011
End Date
May 1 2016
Last Update
September 21 2016
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032