| Silent Cerebral Infarct Transfusion (SIT) trial imaging core: application of novel imaging information technology for rapid and central review of MRI of the brain. | |
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MedLine Citation:
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PMID: 18398653 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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Bruce A Vendt; Robert C McKinstry; William S Ball; Michael A Kraut; Fred W Prior; Bruce Barton; James F Casella; Michael R DeBaun |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial Date: 2008-04-09 |
Journal Detail:
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Title: Journal of digital imaging : the official journal of the Society for Computer Applications in Radiology Volume: 22 ISSN: 1618-727X ISO Abbreviation: J Digit Imaging Publication Date: 2009 Jun |
Date Detail:
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Created Date: 2009-05-08 Completed Date: 2009-08-20 Revised Date: 2011-07-26 |
Medline Journal Info:
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Nlm Unique ID: 9100529 Medline TA: J Digit Imaging Country: United States |
Other Details:
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Languages: eng Pagination: 326-43 Citation Subset: IM |
Affiliation:
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Electronic Radiology Laboratory, Mallinckrodt Institute of Radiology, Washington University School of Medicine, 510 S. Kingshighway, St. Louis, MO 63110, USA. vendtb@mir.wustl.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Anemia, Sickle Cell
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complications*,
pathology Brain / pathology Canada Cerebral Infarction / etiology, pathology* Child France Great Britain Humans Image Processing, Computer-Assisted / methods* Magnetic Resonance Imaging / methods* Mass Screening / methods* Observer Variation Radiology Information Systems* Software United States |
| Grant Support | |
ID/Acronym/Agency:
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U01 NS042804-01A1/NS/NINDS NIH HHS |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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