Journal of the Korean Society of Radiology (대한영상의학회지)

The Korean Society of Radiology (대한영상의학회)
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Central Image Archiving and Management System for Multicenter Clinical Studies: Lessons from Low-dose CT for Appendicitis Trial

다기관 임상연구에서 영상자료의 중앙 저장 및 관리 체계: Low-dose CT for Appendicitis Trial에서의 경험

  • Ko, Yousun (Department of Radiology, Seoul National University Bundang Hospital) ;
  • Choi, Jin Woo (Department of Radiology, The Armed Forces Capital Hospital) ;
  • Kim, Dong Hyun (Department of Radiology, Seoul National University Hospital) ;
  • Lee, Kyong Joon (Department of Radiology, Seoul National University Bundang Hospital) ;
  • Shin, Sang Soo (Department of Radiology, Chonnam National University Hospital) ;
  • Woo, Ji Young (Department of Radiology, Hallym University Kangnam Sacred Heart Hospital) ;
  • Cho, Seong Whi (Department of Radiology, Kangwon National University Hospital) ;
  • Kim, Bong Soo (Department of Radiology, Jeju National University Hospital) ;
  • Lee, Kyoung Ho (Department of Radiology, Seoul National University Bundang Hospital)
  • 교유선 (분당서울대학교병원 영상의학과) ;
  • 최진우 (국군수도병원 영상의학과) ;
  • 김동현 (서울대학교병원 영상의학과) ;
  • 이경준 (분당서울대학교병원 영상의학과) ;
  • 신상수 (전남대학교병원 영상의학과) ;
  • 우지영 (한림대학교 강남성심병원 영상의학과) ;
  • 조성휘 (강원대학교병원 영상의학과) ;
  • 김봉수 (제주대학교병원 영상의학과) ;
  • 이경호 (분당서울대학교병원 영상의학과)
  • Received : 2016.08.09
  • Accepted : 2016.10.27
  • Published : 2017.03.01
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Abstract

This special report aimed to document our experiences in implementing the Central Imaging Archiving and Management System (CIAMS) for a multicenter clinical trial, Low-dose CT for Appendicitis Trial (LOCAT), supported by the Korean Society of Radiology and Radiology Imaging Network of Korea for Clinical Research. LOCAT was a randomized controlled trial to determine whether low-dose CT is non-inferior to standarddose CT with respect to the negative appendectomy rate in patients aged from 15 to 44 years. Site investigators downloaded the CT images from the site picture archiving and communication system servers, and uploaded the anonymized images to the primary server. CIAMS administrators inspected the images routed to the secondary server by a cross-check against image submission worksheets provided by the site investigators. The secondary server was automatically synchronized to the tertiary backup server. Up to June 2016, 2715 patients from 20 sites participated in LOCAT for 30 months. A total of 2539 patients' images (93.5%, 2539/2715) were uploaded to the primary server, 2193 patients' worksheets (80.8%, 2193/2715) were submitted, and 2163 patients' data (79.7%, 2163/2715) were finally monitored. No data error occurred.

본 특별기고는 대한영상의학회 다기관 임상연구 네트워크의 다기관 임상시험(Low-dose CT for Appendicitis Trial; 이하 LOCAT)에서 영상자료 중앙 저장 및 관리 체계의(Central Imaging Archiving and Management System; 이하 CIAMS) 경험을 보고하고자 한다. LOCAT은 충수염이 의심되는 15~44세 환자를 대상으로, 저선량 CT를 받은 환자군의 음성충수 절제율이 표준선량 CT 검사를 받은 환자군에 비해 열등하지 않음을 검증하는 임상시험이다. CIAMS를 기반으로 CT 영상 획득, 저장 및 관리에 일관성을 도모하였다. 각 참여기관의 연구자는 영상자료를 다운로드 받아 익명화하고, 1차 클라우드 서버로 전송한 후, 이에 대한 작업기록지를 CIAMS 관리자에게 제출하였다. 2차 서버로 라우팅된 영상자료를 관리자가 작업기록지와 대조하여 영상자료의 무결성을 모니터링 하였다. LOCAT 개시 후 30개월 동안 20개 기관에서 2715명의 연구 대상자가 등록되었다. 2016년 6월 현재 1차 서버로 영상자료 전송이 완료된 환자가 2539명(93.5%, 2539/2715), 작업기록지 제출이 완료된 환자가 2193명(80.8%, 2193/2715), 모니터링까지 완료된 환자가 2163명(79.7%, 2163/2715)이었다. 이 과정에서 영상자료가 손상된 경우는 없었다.

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Acknowledgement

This research was supported by grants of the Korean Society of Radiology and the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (No. HI13C0004 and HI15C1052). This research work was a part of the investigations of the LOCAT (Low-dOse CT for Appendicitis Trial) Group, which was endorsed by Radiology Imaging Network of Korea for Clinical Research (RINKCR-2015-003). TeraRecon Korea supported the iNtui-tion system. IRM supported Snupi software and the platforms for secondary and tertiary servers.