John Perry

Clinical Trial SoftwareMedical Imaging Resource Center

MIRC OverviewRSNA Clinical Trial and Research SoftwareHands On: Using the RSNA Teaching File

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Clinical Trial Dataflow

DICOM

DICOM

DICOM

Database

HTTP

InternetHTTP / HTTPS

Data AcquisitionSites

Principal InvestigatorSite

X

X

X

Stand-alone application for clinical trials data:Processing and communication

Simple installation and configuration:Single-click installationSingle XML configuration file

Configurable for:Data acquisition sitesPrincipal investigator sites

Platform-independent

CTP

Administrative functions Account management Status display Configuration display System properties display Script editors Authentication

CTP Admin Web Server

DicomObject ImagesSR / KOS / GSPS objects

XmlObjectText dataFlexible schema for identifiers

ZipObjectEncapsulation of trial-specific filesEmbedded manifest to carry the identifiers

CTP Data Objects

A pipeline is an ordered sequence of stages A stage is an element to perform a function:

ImportServiceProcessorStorageServiceExportService

Pipelines can have as many stages as necessary CTP supports multiple pipelines

CTP Processing Pipelines

DicomImportService - DICOM Storage SCP

HttpImportService - HTTP and HTTPS

PollingHttpImportService - HTTP for firewall penetration

DirectoryImportService - manual submission

ArchiveImportService - bulk import

Standard ImportServices

DicomFilter - triage for DicomObjects

XmlFilter - triage for XmlObjects

ZipFilter - triage for ZipObjects

DicomDecompressor - convert DICOM images

DicomPixelAnonymizer - blank pixel regions

DicomAnonymizer - de-identify DicomObjects

XmlAnonymizer - de-identify XmlObjects

ZipAnonymizer - de-identify ZipObject manifests

Standard Processors

ObjectLogger - performance measurementMemoryMonitor - operation monitoring IDMap - PHI ID lookupObjectTracker - data acquisition managementDatabaseVerifier - transfer confirmation between sites

Standard Processors

FileStorageServiceIndexed file managementWeb access with authentication

BasicFileStorageServiceIndexed file management for the National Cancer

Institute NBIA system

Standard StorageServices

DicomExportService - DICOM Storage SCUHttpExportService - HTTP and HTTPSPolledHttpExportService - HTTP for firewall penetrationFtpExportService - FTPDatabaseExportService - external database interface

Standard ExportServices

Configurable tree structure Build-in web server

AuthenticationBrowse patients / studies / data objectsDisplay images (tile / stack / series)Export data objects of all typesProgrammatic access via Ajax servlet

FileStorageService

FileStorageService Viewer

Integrated queue management DatabaseAdapter

Interface between the DatabaseExportService and the database itself

Must be developed for each unique database schemaStandard class to extend for a specific application

DatabaseExportService

1. Name 2. Location; all geographic subdivisions smaller than a

state, including street address, city, county, precinct, zip code, and their equivalent geocodes.

3. Dates (all dates related to the subject of the information, e.g. birth dates, admission dates, discharge dates, encounter dates, surgery dates, etc.)

The HIPAA 18 (1-3)

4. Telephone numbers 5. Fax numbers 6. Electronic mail addresses 7. Social security numbers 8. Medical record numbers 9. Health plan beneficiary numbers

The HIPAA 18 (4-9)

10. Account numbers 11. Certificate / license numbers 12. Vehicle identifiers and serial numbers,

including license plate numbers 13. Device identifiers and serial numbers 14. Web Uniform Resource Locators (URLs)15. Internet Protocol (IP) address numbers

The HIPAA 18 (10-15)

16. Biometric identifiers, including finger and voice prints

17. Full face photographic images and any comparable images

18. Any other unique identifying number, characteristic, or code

The HIPAA 18 (16-18)

Unnecessary PHIRemovalReplacement with values that are the same for all

patients Necessary PHI

Replacement with values that allow subjects, studies, and images to be related to one-another, but that do not allow identification of the human being

De-indentification

Published in 2009 Defines de-identification profiles Basic Profile: most aggressive Several options for relaxing certain IDs This is a major contribution: it provides expert

guidance for the de-identification of complex datasets

DICOM Supplement 142

Fully scriptable de-identification instructions DICOM Anonymizer Configurator

Web UI for creating and editing scriptsSupport for DICOM Supplement 142 profiles

Profile scripts written by Justin Kirby at NCI Support for user-defined profiles

Default script: 142 Basic

CTP DicomAnonymizer

CTP Example

CTP

DicomImportServiceDicomAnonymizerHttpExportService

Data Acquisition Site

CTP

HttpImportServiceFileStorageServiceDatabaseExportServiceDicomExportService

Principal Investigator Site

…Modality

PACS

External DatabaseWorkstation

Local Disk

Firewall Penetration

DMZ

CTPPollingHttpImportService… (additional stages)

Secure Network

CTPHttpImportServicePolledHttpExportService

DMZ

InternetHTTP / HTTPS

Principal Investigator Site

Flexible All standard stages are highly configurable

Extensible Integrated class loader Interface-based structureAbstract classes for easy development of new stagesBase class for developing database interfaces

Adapting CTP

Runs on Windows, Mac, Linux, SolarisRequires only Java Java and CTP are freeMIRC/CTP Users Meeting:

Monday, 12/29, from 3:00-4:15 in N127

CTP

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