Lead Investigator Shannon First Name Lead Investigator G. Middle Initial Lead Investigator Farmakis Last Name Lead Investigator M.D. Degree Institution St. Louis University School of Medicine Current Department of Radiology Institution Department Rank or Position Medical Director of Pediatric Radiology and Assistant Professor of Radiology and Pediatrics Address 3635 Vista Ave. at Grand Blvd. St. Louis, MO 63110 United States Phone Number (314) 268-5782 Fax (314) 268-5116 Training Dates Diagnostic Radiology Residency 7/2009-6/2013 Pediatric Radiology Fellowship 7/2013-6/2014 Email farmakis@slu.edu Upload Cover Letter spr_cover_letter.docx 18.65 KB · DOCX Is this No application based on an application submitted to this or any other organization in the past two years? Project Title Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the pediatric population Abstract of Proposed Research Plan (300 words) Background: Pediatric liver disease continues to remain a major focus of research. This has taken on greater relevance with the rise in pediatric obesity which, in addition to several other well-characterized liver diseases, causes liver fibrosis. The degree of fibrosis is generally well-accepted as both a measurement of disease severity and a prognostic indicator. Unfortunately, the current gold standard to assess fibrosis remains a liver biopsy, which, in addition to anesthesia risks and sampling errors, can result in profound hemorrhage, infections, and even mortality. Thus, there is a great need for reliable, non-invasive biomarkers of hepatic fibrosis. Sonoelastography has emerged as a method of evaluating liver disease. Hypothesis: We hypothesize that shear wave sonoelastography (SWE) measurements will correlate with the histopathologic assessment of liver fibrosis in pediatric patients. Specific Aims: To perform SWE on pediatric patients with known liver disease who undergo a liver biopsy within one month of the ultrasound exam in order to determine the accuracy of SWE in evaluating the various stages of liver fibrosis using the Ishak and METAVIR histopathologic scale. As a control, we will perform SWE on patients without liver disease to establish baseline measurements in a normal liver. Potential Impact: We believe that SWE may represent an accurate, reliable, and noninvasive method of staging liver fibrosis in pediatric patients and may obviate the need for performing liver biopsies in evaluating liver disease. Our study has the potential to accelerate the adoption of this less invasive approach into wide practice within the next 2-3 years. This is because liver ultrasound is already well established in pediatrics, the equipment is present in many centers, and the benefit to avoiding liver biopsy is well recognized. Upload: Detailed plan and detailed_plan_farmakis.docx 18.33 KB · DOCX bibliography Resources and The study will take place in the Pediatric Imaging Department at SSM Cardinal Glennon Environment: Children’s Medical Center in St. Louis, MO. The exams will be performed in the ultrasound examination rooms using our two GE Logiq E9 ultrasound machines which are equipped with the elastography software. We currently have 3 ultrasound exam rooms. Major We have 2 GE Logiq E9 ultrasound machines with the capability of performing shear Equipment: wave sonoelastography. Fiscal Office of Sponsored Programs Administration at St. Louis University Agent/Institution Award Payee Joseph First Name Award Payee Last Sanning Name Award Payee CPA Title Checks payable Joseph Sanning, CPA to: Award Payee Address Fusz Memorial Hall, Room 368 3700 West Pine Mall St. Louis, MO 63108-3306 United States Award Payee (314) 977-2380 Phone Number Award Payee grants@slu.edu Email Grant Marsha Administrator's First Name Grant Bennet Administrator's Last Name Grant Director, Department of Radiology Administrator's Title Grant Radiology Administrator's Department Grant Administrator's 3635 Vista Avenue Address St. Louis, MO 63110 United States Grant (314) 577-8223 Administrator's Phone Number Grant Administrator's Email bennetm@slu.edu Upload Letters of Recommendation 1 chairman_letter.pdf 436.76 KB · PDF Upload Letter of Recommendation 2 teckman_letter.pdf 354.70 KB · PDF Upload Budget budget.docx 11.77 KB · DOCX Upload Curriculum Vitae farmakis_vitae.docx 29.24 KB · DOCX Upload Research Assurances approvalletter_irb.pdf 57.51 KB · PDF