Skip to main content
SpringerLink
Log in

DICOM for Clinical Research: PACS-Integrated Electronic Data Capture in Multi-Center Trials

  • Published:
Journal of Digital Imaging Aims and scope Submit manuscript

Abstract

Providing surrogate endpoints in clinical trials, medical imaging has become increasingly important in human-centered research. Nowadays, electronic data capture systems (EDCS) are used but binary image data is integrated insufficiently. There exists no structured way, neither to manage digital imaging and communications in medicine (DICOM) data in EDCS nor to interconnect EDCS with picture archiving and communication systems (PACS). Manual detours in the trial workflow yield errors, delays, and costs. In this paper, requirements for a DICOM-based system interconnection of EDCS and research PACS are analysed. Several workflow architectures are compared. Optimized for multi-center trials, we propose an entirely web-based solution integrating EDCS, PACS, and DICOM viewer, which has been implemented using the open source projects OpenClinica, DCM4CHEE, and Weasis, respectively. The EDCS forms the primary access point. EDCS to PACS interchange is integrated seamlessly on the data and the context levels. DICOM data is viewed directly from the electronic case report form (eCRF), while PACS-based management is hidden from the user. Data privacy is ensured by automatic de-identification and re-labelling with study identifiers. Our concept is evaluated on a variety of 13 DICOM modalities and transfer syntaxes. We have implemented the system in an ongoing investigator-initiated trial (IIT), where five centers have recruited 24 patients so far, performing decentralized computed tomography (CT) screening. Using our system, the chief radiologist is reading DICOM data directly from the eCRF. Errors and workflow processing time are reduced. Furthermore, an imaging database is built that may support future research.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6

Similar content being viewed by others

Notes

  1. http://cbiit.nci.nih.gov/ncip/about-ncip/

  2. https://code.google.com/p/imagedc/

  3. http://www.oracle.com/

  4. http://www.mednetstudy.com/technology/imednetedc/

  5. http://www.astclinical.com/solution.html

  6. http://www.agmednet.com/clinical-trials-solutions/

  7. http://www.clinicalstudio.com/features/dicom-image-management/

  8. http://ingenium.home.xs4all.nl/dicom.html

  9. http://ivmartel.github.io/dwv/

  10. http://idmteam.github.io/oc-big/

  11. http://www.dcm4che.org/confluence/display/ee2/Home

  12. http://www.dcm4che.org/confluence/display/WEA/Home

References

  1. Mandrekar SJ, Sargent DJ: Drug designs fulfilling the requirements of clinical trials aiming at personalizing medicine. Chin Clin Oncol 3(2):14, 2014

    PubMed Central  PubMed  Google Scholar 

  2. Miller CG, Krasnow J, Schwartz LH: Medical Imaging in Clinical Trials. Springer London, London, 2014

    Book  Google Scholar 

  3. Mildenberger P, Eichelberg M, Martin E: Introduction to the DICOM standard. Eur Radiol 12(4):920–927, 2002

    Article  PubMed  Google Scholar 

  4. Lepanto L, Paré G, Aubry D, Robillard P, Lesage J: Impact of PACS on dictation turnaround time and productivity. J Digit Imaging 19(1):92–97, 2006

    Article  PubMed Central  PubMed  Google Scholar 

  5. Fenstermacher D, Street C, McSherry T, Nayak V, Overby C, Feldman M: The cancer biomedical informatics Grid (caBIGTM). In: IEEE Engineering in Medicine and Biology 27th Annual Conference; 2005, p 743–746

  6. Gentili A, Chung CB, Hughes T: Use of the MIRC DICOM service for clinical trials to automatically create teaching file cases from PACS. Radiographics 27(1):269–275, 2007

    Article  PubMed  Google Scholar 

  7. Gao Y, Burns SS, Lauzon CB, Fong AE, James TA, Lubar JF, et al: Integration of XNAT/PACS, DICOM, and research software for automated multi-modal image analysis. In: SPIE Medical Imaging; 2013, p 867405

  8. Welker JA: Implementation of electronic data capture systems: barriers and solutions. Contemp Clin Trials 28(3):329–336, 2007

    Article  PubMed  Google Scholar 

  9. van Herk M: Integration of a clinical trial database with a PACS. JPCS 489:12099, 2014

    Google Scholar 

  10. Koutelakis GV, Lymperopoulos DK: PACS through web compatible with DICOM standard and WADO service: advantages and implementation. In: International Conference of the IEEE Engineering in Medicine and Biology Society, 2006, p 2601–2605

  11. Skripcak T: Lessons learned from integrating OpenClinica with other IT systems [Internet]. Available from: https://community.openclinica.com/sites/fileuploads/akaza/cms-community/Tomas%20Skripcak%20-%20Lessons%20learned.pdf. Accessed 19 May 2015

  12. Deserno TM, Deserno V, Haak D, Kabino K: Digital imaging and electronic data capture in multi-center clinical trials. Accepted on Medinfo 2015

  13. Haak D, Page CE, Deserno TM: Workflow-based integration of EDCS and PACS supporting image-based surrogates in clinical trials. Accepted on MIE 2015

  14. Haak D, Samsel C, Gehlen J, Jonas S, Deserno TM: Simplifying electronic data capture in clinical trials: workflow embedded image and biosignal file integration and analysis via web services. J Digit Imaging 27(5):571–580, 2014

    Article  PubMed  Google Scholar 

  15. Pavlović I, Kern T, Miklavcic D: Comparison of paper-based and electronic data collection process in clinical trials: costs simulation study. Contemp Clin Trials 30(4):300–316, 2009

    Article  PubMed  Google Scholar 

  16. Franklin JD, Guidry A, Brinkley JF: A partnership approach for electronic data capture in small-scale clinical trials. J Biomed Inform 44:103, 2011

    Article  Google Scholar 

  17. Warnock MJ, Toland C, Evans D, Wallace B, Nagy P: Benefits of using the DCM4CHE DICOM archive. J Digit Imaging 20(S1):125–129, 2007

    Article  PubMed Central  PubMed  Google Scholar 

  18. Haak D, Page CE, Kabino K, Deserno TM: Evaluation of DICOM viewer software for workflow integration in clinical trials. In: SPIE Medical Imaging, 2015, p 94180

  19. Onken M, Riesmeier J, Engel M, Yabanci A, Zabel B, Després S: Reversible anonymization of DICOM images using automatically generated policies. Stud Health Technol Inform 150:861–865, 2009

    PubMed  Google Scholar 

  20. Parkinson J: Getting real in clinical trials. Nat Rev Drug Discov 13(9):639–640, 2014

    Article  CAS  PubMed  Google Scholar 

  21. Lu Z, Su J: Clinical data management: current status, challenges, and future directions from industry perspectives. OAJCT 2:93–105, 2010

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Medical Informatics, Uniklinik RWTH Aachen, Pauwelsstr. 30, 52074, Aachen, Germany

    Daniel Haak, Charles-E. Page & Thomas M. Deserno

  2. Department of Diagnostic and Interventional Radiology, Uniklinik RWTH Aachen, Pauwelsstr. 30, Aachen, 52074, Germany

    Sebastian Reinartz

  3. Department of Cardiology, Uniklinik RWTH Aachen, Pauwelsstr. 30, Aachen, 52074, Germany

    Thilo Krüger

Authors
  1. Daniel Haak
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Charles-E. Page
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Sebastian Reinartz
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Thilo Krüger
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Thomas M. Deserno
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Daniel Haak.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Haak, D., Page, CE., Reinartz, S. et al. DICOM for Clinical Research: PACS-Integrated Electronic Data Capture in Multi-Center Trials. J Digit Imaging 28, 558–566 (2015). https://doi.org/10.1007/s10278-015-9802-8

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10278-015-9802-8

Keywords

Search

Navigation