Dr. Paul Harmatz, Dr. Elliott Vichinsky, and their research associates at Children’s Hospital and Research Center at Oakland are conducting a study to compare the accuracy and precision of SQUID-ferritometer measurements to liver iron measured in liver biopsy samples. The collected data will be used to file an FDA approval application for the SQUID-ferritometer as a non-invasive method for liver iron assessment. This study was started in 2003 and will be open for enrollment to 40 subjects who meet the criteria listed below.
Who can participate?
- Patients who are older than five years
- Patients who have been diagnosed with thalassemia or sickle cell disease
- Patients who are able to lie down still for at least 30 minutes without sedation
- Patients who have had a liver biopsy recommended by a health care provider as part of their thalassemia care
What does the study involve?
- Patients with severe liver damage (cirrhosis)
- Patients who receive drugs for a clinical therapy study at the time the evaluation procedures are completed
- Patients who have electrical devices such as pacemakers or infusion pumps, which cannot be removed for the MRI
- Patients will be asked to have their liver iron measured by SQUID-ferritometer at the HEDCO Health Science Center which is located at Children’s Hospital Oakland, Research Center, (CHORI) a few blocks away from the main hospital.
- Patients will be asked to undergo a clinically indicated liver biopsy which will be completed at Children’s Hospital Research Center at Oakland.
- A chart review will be done to obtain a patient’s medical history.
The SQUID measurement will be completed with no charge to patients, but insurance companies will be charged for the liver biopsy, as it will be completed as a clinically indicated liver biopsy.
Are there any possible risks related to the SQUID measurements?
For more information, please contact Zahra Pakbaz, MD at Children's Hospital & Research Center at Oakland, 510-428-3885, ext. 4248 or ask your clinical care provider.
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