Validation of Biosusceptometry as a Non-Invasive Technique for Assessment of Liver Iron

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?

    Inclusion Criteria
  • 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
    Exclusion Criteria
  • 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
What does the study involve?
  • 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?

  • The SQUID-ferritometer is considered to be a safe investigational device, and no risk related to the SQUID-ferritometer is expected.

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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