Abstract
The Silent Cerebral Infarct Multicenter Transfusion (SIT) Trial is a multi-institutional intervention trial in which children with silent cerebral infarcts are randomized to receive either blood transfusion therapy or observation (standard care) for 36 months. The SIT Trial is scheduled to enroll approximately 1,880 children with sickle cell disease from 29 clinical sites in the United States, Canada, UK, and France. Each child undergoes a screening magnetic resonance imaging (MRI) of the brain to detect the presence of silent cerebral infarct-like lesions, a pre-randomization (baseline) MRI and exit MRI to determine if there are new or enlarged cerebral infarcts, using a designated, prospective imaging protocol. The objective of this manuscript is to describe the innovative method used to process and adjudicate imaging studies for an international trial with a primary endpoint that includes neuroimaging. Institution investigators at each site were provided with computer hardware and software for transmission of MRI images that allow them to strip the scans of all personal information and add unique study identifiers. Three neuroradiologists at separate academic centers review MRI studies and determine the presence or absence of silent cerebral infarct-like lesions. Their findings are subsequently placed on web-based case report forms and sent to the Statistical Coordinating Center. The average time from imaging center receipt of the MRI study to the radiology committee report back to the local site is less than two working days. This novel strategy was designed to maximize efficiency and minimize cost of a complex large multicenter trial that depends heavily on neuroimaging for entry criteria and assessment for the primary outcome measures. The technology, process, and expertise used in the SIT Trial can be adapted to virtually any clinical research trial with digital imaging requirements.
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Acknowledgments
Substantial contributions to the study were also made by individual members from the following SIT Trial committees: Executive Committee—Michael R. DeBaun, MD, MPH (Chair, Co PI for the SIT Trial), Washington University in St. Louis School of Medicine, Bruce Barton, PhD, (PI for the Statistical Coordinating Center) Maryland Medical Research Institute, Inc., James F. Casella, MD (Vice-Chair and Co-PI for the SIT Trial), Johns Hopkins University School of Medicine, Deborah Hirtz, MD, National Institute of Neurological Disorders and Stroke, Rebecca N. Ichord, MD, Children’s Hospital of Philadelphia, Robert C. McKinstry, MD, PhD, Michael Noetzel, MD, Washington University School of Medicine, Fred Prior, PhD, Mallinckrodt Institute of Radiology, Washington University, and Desiree A. White, PhD, Washington University. Neuropsychology Committee—Desiree A. White, PhD (Chair), Washington University, T. David Elkin, PhD, University of Mississippi Medical Center, Kevin R. Krull, PhD, Baylor College of Medicine, Kimberly Rennie, PhD, Medical College of Wisconsin, and H. Gerry Taylor, PhD, Rainbow Babies and Children’s Hospital. Neuroradiology Committee—Robert C. McKinstry, MD, PhD (Chair), Washington University School of Medicine, William S. Ball, Jr., MD, University of Cincinnati, Michael A. Kraut, MD, PhD, Johns Hopkins University School of Medicine, and Marilyn Siegel, MD, Washington University School of Medicine. Neurology Committee—Michael J. Noetzel, MD, (Chair) Washington University School of Medicine, Rebecca N. Ichord, MD, Children’s Hospital of Philadelphia, E. Steve Roach, MD, Children’s Research Institute, The Ohio State University, Deborah Hirtz, MD, National Institute of Neurological Disorders and Stroke, and Michael Dowling, MD, PhD, University of Texas Southwestern Medical Center. The following investigators participated in the Silent Infarct Transfusion Trial: Michael R. DeBaun, MD, MPH, Washington University School of Medicine, St. Louis, MO.; Bruce Barton, PhD, Maryland Medical Research Institute, Inc., Baltimore, MD.; Fred Prior, PhD, Mallinckrodt Institute of Radiology at the Washington University School of Medicine, St. Louis, MO.; James F. Casella, MD, Harold Lehmann, MD and John J. Strouse, MD, Johns Hopkins University School of Medicine, Baltimore, MD; Scott T. Miller, MD, State University of New York-Downstate Medical Center/Kings County Hospital Center, Brooklyn, NY; Caterina Minniti, MD, Children’s Research Institute–Children’s National Medical Center, Washington, DC; Rupa Redding-Lallinger, MD, University of North Carolina at Chapel Hill, Chapel Hill, NC; Charles Daeschner, MD, East Carolina University, Greenville, NC; Anthony Villella, MD, Case Western Reserve University/Rainbow Babies and Children’s Hospital, Cleveland, OH; Mark A. Ranalli, MD, Columbus Children’s Hospital/Ohio State University College of Medicine and Public Health, Columbus OH; Karen Kalinyak, MD, University of Cincinnati, Cincinnati, OH; Mark Heiny, MD, Riley Hospital for Children/Indiana University, Indianapolis, IN; Ingrid A. Sarnaik, MD, Wayne State University, Detroit, MI; Alexis A. Thompson, MD, Northwestern University–Children’s Memorial Hospital, Chicago, IL; Julie Panepinto, MD, MSPH, Medical College of Wisconsin/Children’s Research Institute of the Children’s Hospital of Wisconsin, Milwaukee, WI; Gerald M. Woods, MD, University of Missouri-Kansas/Children’s Mercy Hospital, Kansas City, MO; Allison King, MD, MPH, Washington University School of Medicine/St. Louis Children’s Hospital, St. Louis, MO; Suzanne L. Saccente, MD, University of Arkansas/Arkansas Children’s Hospital Research Institute, Little Rock, AK.; Thomas Howard, MD, University of Alabama at Birmingham, Birmingham, AL; Rathi V. Iyer, MD, University of Mississippi Medical Center, Jackson, MS.; Gladstone Airewele, MD, MPH and Donald H. Mahoney, Jr., MD, Baylor College of Medicine, Houston, TX; Charles Scher, MD, Tulane University Health Sciences Center, New Orleans, LA; Charles T. Quinn, MD, University of Texas Southwestern Medical Center, Dallas, TX; Thomas Coates, MD, University of Southern California, Los Angeles, CA; Hernan Sabio, MD, Wake Forest School of Medicine, Winston-Salem, NC; Fenella Kirkham, MD, University College Hospital, Institute of Child Health, London, United Kingdom; Baba Inusa, MD, Guy’s and St. Thomas’ Foundation Trust, London, United Kingdom; Françoise Bernaudin, MD, Hôpital Intercommunal de Créteil, Créteil, France; Melanie A. Kirby, FRCP, The Hospital for Sick Children, Toronto, ON; and Deborah Hirtz, MD, National Institutes of Health (NINDS), Bethesda, MD.
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Vendt, B.A., McKinstry, R.C., Ball, W.S. et al. Silent Cerebral Infarct Transfusion (SIT) Trial Imaging Core: Application of Novel Imaging Information Technology for Rapid and Central Review of MRI of the Brain. J Digit Imaging 22, 326–343 (2009). https://doi.org/10.1007/s10278-008-9114-3
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DOI: https://doi.org/10.1007/s10278-008-9114-3