Abstract #3024

INCORPORATING MRS BIOMARKERS INTO MULTICENTER CLINICAL TRIALS: QUALITY ASSURANCE RESULTS FROM THE HIGH-DOSE ERYTHROPOIETIN FOR ASPHYXIA AND ENCEPHALOPATHY (HEAL) TRIAL

Jessica L Wisnowski^1,2, Yvonne W Wu³, Ashok Panigrahy⁴, Amit M Mathur⁵, Sandra E Juul⁶, Robert C McKinstry⁷, and Stefan Bluml¹

¹Radiology, Children's Hospital Los Angeles, Los Angeles, CA, United States, ²Fetal and Neonatal Institute, Division of Neonatology, CHLA Dept. of Pediatrics, University of Southern California, Los Angeles, CA, United States, ³Neurology, University of California, San Francisco, San Francisco, CA, United States, ⁴Radiology, University of Pittsburgh, Pittsburgh, PA, United States, ⁵Pediatrics, Division of Neonatology, Washington University, St. Louis, MO, United States, ⁶Pediatrics, Division of Neonatology, University of Washington, Seattle, WA, United States, ⁷Radiology, Washington University, St. Louis, MO, United States

MR Spectroscopy (MRS) provides early biomarkers of brain injury and treatment response in neonates with hypoxic-ischemic encephalopathy. We present preliminary data from the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) Trial (NCT02811263), comparing quality assurance parameters across MR vendors. Overall, we have been able to analyze MRS data obtained from 85% of patients who underwent MRI, although this rate is lower at sites operating GE MR systems. 92% of spectra met quality standards, with slight differences in FWHM and SNR by vendor. Overall, these data demonstrate the feasibility of obtaining reliable MRS data in a multicenter neonatal randomized controlled trial.

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