Multicenter clinical trials of imaging workstations and methods

Infrastructure to support multicenter clinical trials of imaging work-stations and methods in oncologic applications has been developed by the American College of Radiology Imaging Network (ACRIN). This infrastructure was assembled and tested in a retrospective trial of virtual colonography where 117 examinations from 8 centers were evaluated on 3 workstations (GE, Mayo, Vital Images) by 18 observers. The infrastructure consists of specialized applications to homogenize DICOM images from multiple manufacturers using ail ACR-specific manufacturer code, data conditioning and archiving, observer-based rated response evaluation, and biostatistical analysis of results. A group of networked (Fibre Channel) servers with Microsoft 2000 Server OS and Microsoft SQL Server software collectively acquire, manage, and process images and related clinical research data, including observations. A server is dedicated to document image management for paper forms and ancillary information (e.g., pathology reports) received from various sites, keyed to anonymized case records. In general, patient identifiers are removed and individual identities cannot be associated with specific data sets at ACRIN Headquarters. In sonic cases, site principal investigators may have the key lists that would permit this identification, but the information is not shared with ACRIN.