Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2015 Oct;28(5):558-66.
doi: 10.1007/s10278-015-9802-8.

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

Daniel Haak  1 , Charles-E Page  2 , Sebastian Reinartz  3 , Thilo Krüger  4 , Thomas M Deserno  2
Affiliations

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

Daniel Haak et al. J Digit Imaging. 2015 Oct.

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.

Keywords: Clinical trial; Digital Imaging and Communications in Medicine (DICOM); Open source; PACS; Systems integration; Workflow.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Various strategies for integration of DICOM image data into EDCS [12]
Fig. 2
Fig. 2
Proposed architecture for connecting EDCS and PACS
Fig. 3
Fig. 3
Storage of DICOM objects in the EDCS
Fig. 4
Fig. 4
Retrieval of DICOM objects from the EDCS
Fig. 5
Fig. 5
Resulting workflow in the VitaVasK study for storage and retrieval of DICOM data
Fig. 6
Fig. 6
Workflow of clinical trials EDC with (left) and without (right) image integration (adopted from [14])
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Mandrekar SJ, Sargent DJ. Drug designs fulfilling the requirements of clinical trials aiming at personalizing medicine. Chin Clin Oncol. 2014;3(2):14. - PMC - PubMed
    1. Miller CG, Krasnow J, Schwartz LH. Medical Imaging in Clinical Trials. London: Springer London; 2014.
    1. Mildenberger P, Eichelberg M, Martin E. Introduction to the DICOM standard. Eur Radiol. 2002;12(4):920–927. doi: 10.1007/s003300101100. - DOI - PubMed
    1. Lepanto L, Paré G, Aubry D, Robillard P, Lesage J. Impact of PACS on dictation turnaround time and productivity. J Digit Imaging. 2006;19(1):92–97. doi: 10.1007/s10278-005-9245-8. - DOI - PMC - PubMed
    1. 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 - PubMed