Silent Cerebral Infarct Transfusion (SIT) trial imaging core: application of novel imaging information technology for rapid and central review of MRI of the brain

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.

Figures

Fig 1

ERL network infrastructure for SIT Trial image collection and management.

Fig 2

CSW program screen showing changes being made to the Patient Name and ID.

Fig 3

ERL check-in screen.

Fig 4

SIT Trial MRI status tracking log.

Fig 5

Philips iSite radiology system.

Fig 6

Quarterly display calibration test pattern.

Fig 7

Web-based radiologist worklist.

Fig 8

SIT Trial incidental findings case report form.

Fig 9

SIT Trial screening (MRI-1) study case report form.

Fig 10

SIT Trial consensus results.

Fig 11

SIT Trial consensus case report form.

Fig 12

SIT Trial lesion location and measurement case report form.

Fig 13

SIT Trial report to the Neurology Committee.

Fig 14

ERL Weekly MRI Findings Report.

Fig 15

Number and type of SIT Trial imaging studies received by month.

Fig 16

Time from scan date to receipt at ERL (as of April 30, 2007).

Fig 17

SIT Trial Radiology Committee processing time for the last 12 months.

Fig 18

Traditional clinical trial image processing.