J Nucl Med. 2008; 49 (Supplement 1):155P
InfoSNM Computer PresentationsInfoSNM I |
How the Imaging Core Lab builds and implements service modules for use in clinical PET/CT trials
Jun Zhang1,
Nathan Hall1,
Craig O'Dell1,
Justin Sandver1,
Richard Jacko1,
Milan Koppen1 and
Michael Knopp1
1 Radiology, The Ohio State University Medical Center, Columbus, Ohio
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Learning Objectives: To introduce how the Imaging Core Lab (ICL) builds and implements important components for use in clinical PET/CT trials.
Abstract (summary): The ICL has accumulated extensive experience and collaborated with numerous sites and PET/CT manufacturers in clinical trials. Five components were established for clinical trials in the ICL. The facilities component includes proprietary scanners and vendor workstations, forming the ICL infrastructure. An administrative component was organized to integrate the infrastructure together with dedicated individuals in trial implementations. The implementations were performed strictly according to the third component, Standard Operation Procedures (SOP), in regular core lab meetings, training sessions and quality assurance (QA). Dedicated Technical Site Manuals were developed for each participating site, within which protocols for imaging acquisition, ICL-site communication, specific trial emails and FTP servers, data archiving and transfer, WebEx meetings as well as equipment validation were documented. Data receipt confirmation and quality check (QC) reports as part of the QA component were implemented in SOPs to verify compliance with protocol guidelines. ICL performs an on-site or virtual site visit as the credentialing component for site qualifying assessment. Automatic and semi-automatic programs as the post-processing component were developed for the standardized data processing of DICOM archives, database management, QC and data de-identification. These outlined components were integrated in the ICL SOP implementations and have shown a satisfactory achievement in standard operations and guidelines, and have lead to the successful completion of clinical PET/CT trials.
