TY - JOUR
T1 - Silent cerebral infarct transfusion (SIT) trial imaging core
T2 - Application of novel imaging information technology for rapid and central review of MRI of the brain
AU - Vendt, Bruce A.
AU - McKinstry, Robert C.
AU - Ball, William S.
AU - Kraut, Michael A.
AU - Prior, Fred W.
AU - Barton, Bruce
AU - Casella, James F.
AU - Debaun, Michael R.
N1 - Funding Information:
There is currently no systematic strategy to identify or treat children with silent cerebral infarction to prevent the significant neurological morbidity and risk of further neurological compromise associated with this finding. The Silent Cerebral Infarct Transfusion (SIT) Trial is a cooperative study performed by 28 pediatric study centers in collaboration with a clinical coordinating center, a statistical and data coordinating center, and staff from the National Institute of Neurological Disorders and Stroke (NINDS), Rockville, Maryland. This work is supported by funding from NINDS #U01 NS042804 (Clinical Trials.gov). In the SIT Trial, children with silent cerebral infarcts are randomized to receive either blood transfusion therapy or observation (standard care) for 36 months. The primary hypothesis is that monthly prophylactic blood transfusion therapy in children with silent cerebral infarcts will result in an 86% reduction in the proportion of children with clinically evident strokes or new or progressive silent cerebral infarcts.
PY - 2009/6
Y1 - 2009/6
N2 - 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.
AB - 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.
KW - Case report forms
KW - Central review
KW - Clinical trial imaging
KW - PHI
UR - http://www.scopus.com/inward/record.url?scp=67349169769&partnerID=8YFLogxK
U2 - 10.1007/s10278-008-9114-3
DO - 10.1007/s10278-008-9114-3
M3 - Article
C2 - 18398653
AN - SCOPUS:67349169769
SN - 0897-1889
VL - 22
SP - 326
EP - 343
JO - Journal of Digital Imaging
JF - Journal of Digital Imaging
IS - 3
ER -