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|Principal Investigator:||Maureen Jonas
|Trial Description:||The purpose of this research study is to determine the effectiveness of the FibroScan medical device and new blood tests to detect and evaluate the severity of liver scarring (fibrosis) in children. The study involves testing an investigational device. This means the device has not yet been approved by the Food and Drug Administration (FDA).
The FibroScan measures liver stiffness with an ultrasound scan. The machine produces a low amplitude mechanical sound wave like a flick. This gives rise to a low frequency elastic wave called a shear wave. The speed of this wave is directly related to the measurement of liver elasticity. While this wave travels through the skin, fat tissue and liver, ultrasound readings are performed. These readings are used to measure the velocity or speed of the wave and thus deduce the elasticity of the liver. The elasticity of the liver is changed with more severe liver scarring or fibrosis. In addition, there are new blood tests which can detect blood levels which are elevated when liver fibrosis occurs.
The object of the research is to investigate the FibroScan device and new blood tests as alternate tools for measuring scar tissue in the liver and in the future, potentially avoid the need for repeat liver biopsies.
|Recruitment Info:||Inclusion criteria
• Subjects who have had a liver biopsy in the past 1 year
• Informed consent has been obtained from parent/guardian.
• Subjects allow liver stiffness measurement and provide a blood sample.
• Control subjects for the serum fibrosis marker arm must be without known liver disease (ALT within normal
range for age) and allow additional 5 cc of blood to be drawn at a time of phlebotomy for standard medical care.
• Uninterpretable or unavailable biopsy specimen
• Lack of critical clinical, biochemical and/or demographic information
• Morbid obesity: Body Mass Index > 40
• Implantable cardiac device
|Recruitment Contact Name:||Christine Lee
|Recruitment Contact Phone:||617-355-0492
|Recruitment Contact Email:||N/A