PARTICIPATING IN ADVANCED TECHNOLOGY TRIALS Roxana Haynes, RN,BSN

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PARTICIPATING IN ADVANCED TECHNOLOGY TRIALS
Roxana Haynes, RN,BSN

• Image-Guided Therapy Center (ITC)
• Washington University, St. Louis, Mo.

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Frequently Asked Question

• What is the ITC, the ATC? Whats the
  difference?
• The ATC is the Advanced Technology Consortium.
  Its members include the ITC, RPC, RTOG, QARC,
  RCET. The members work in conjunction to
  facilitate the advancement of the advanced
  technology clinical trials.

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Advanced Technology Consortium for Clinical
Trial QA

• NCI Grant U24 CA 081647
• Image-Guided Therapy Center (ITC Washington
  University in St. Louis)
• Resource Center for Emerging Technologies (RCET
  University of Florida in Gainesville)
• Radiological Physics Center (RPC M.D. Anderson
  Cancer Center)
• Radiation Therapy Oncology Group (RTOG)
• Quality Assurance Review Center (QARC)

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Advanced Technology Consortium

• Provides support for advanced technology clinical
  trials
• Digital data submission of elements necessary for
  review and analysis of advanced technology trials
• Coordinate Quality Assurance efforts between
  clinical trials quality assurance centers
• Develop uniform credentialing requirements across
  quality assurance centers.

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Advanced Technology Consortium

• At this time, RTOG participants need to deal
  with
• Image-Guided Therapy Center (ITC)-
  Washington University, St. Louis
• Radiologic Physics Center (RPC)

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Requirements for conducting multi-institutional
clinical trials involving 3D imaged based planning

• Collect treatment planning data
• Paper forms are inadequate for volumetric TP
  data.
• Participants must be able to submit TP data
  digitally.
• Review 3D data to monitor protocol conformance
• Volume definitions
• Dosimetry TV coverage, OAR avoidance
• Develop and test dose-response models
• 3D dosimetry (including fractionation)
• Clinical outcomes

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RTOG Digital Data Protocols (Jan, 2007)
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14 RTOG Digital Data Protocols (Jan, 2007)
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1 NSABP/RTOG ATC Supported Open Protocol
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• June 22 2006 ATC Mtg 3913 Complete Digital Data
  Sets Submitted Over 12 Year Period using ATC
  Method 1

• 15 commercial RTP systems have implemented export
  capability
• 418 institutions able to submit data

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ATC Website http//atc.wustl.edu

• Facility Questionnaires
• Dry Run Test Guides
• Data submission forms
• Data submission checklists
• QA Guidelines (by protocol)
• Protocol text

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Frequently Asked Question

• What to send (and where) for ATC-supported
  protocols?
• Section 12.2 in the RTOG protocols normally lists
  what is to be sent to ITC
• The ATC website will also have a data submission
  checklist that lists what needs to be sent
• The ITC address and contact information is on the
  ATC website
• Image Guided Therapy QA Center
• 4511 Forest Park, Suite 200
• St. Louis, Mo. 63108

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Frequently Asked Question

• We want to participate in RTOG Protocol ???? --
  What do I need to do?
• First, please refer to the ATC website
  http//atc.wustl.edu click on specific protocol
  number
• You will need to be credentialed.
• You will need to setup an FTP account to send
  data.
• You must be able to submit four items to ITC
• Digital treatment planning data (in RTOG or DICOM
  format)
• DDSI form (online web form)
• Color isodoses
• Email to ITC after submitting digital data

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Frequently Asked Question

• What is an FTP account and how do I get one?
• An FTP account allows your institution to send
  electronic digital data (from your treatment
  planning system) to the ITC.
• Only one account is issued to an institution and
  is used for all studies that require digital data
  to be sent to the ITC.
• At most institutions, it is the Physicist or
  dosimetrist who send the digital data.

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How to submit digital data to the ITC

• Request SFTP Account by email to
  ITC_at_castor.wustl.edu
• Include Institution name, address, and contact
  phone number (Physicist RA), RTF
• ITC now using SFTP (Secure FTP) important to
  use FTP client software which allows SFTP
  transmission
• Media
• Send media by express mail to ITC in St. Louis
• Media accepted CD or 4 mm DAT tape

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Frequently Asked Question

• What do I need to do to become credentialed?
• First, please visit the ATC website
  (http//atc.wustl.edu) and select the page for
  the protocol for which you want to be
  credentialed.
• Credentialing requirements are protocol specific
  and may include any or all of the following
• Online Facility Questionnaire
• Dry Run (previously-treated patient, planned
  per protocol with digital treatment planning
  data submitted to the ITC.
• Phantom contact the RPC to request a phantom.
  The phantom will be mailed to your institution.
  Plan and irradiate according to instructions and
  submit treatment planning data with color
  isodoses to the ITC.

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Commercial Treatment Planning Systems Capable of
Submitting ATC- Compliant Digital Data
R RTOG Data Exchange Format D DICOM RT Objects
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Credentialing

• Many protocols are credentialed by the RPC
• Items may need to be sent both the RPC and the
  ITC.
• Examples of studies that utilize both digital
  data submission and RPC credentialing
• B39/RTOG 0413 Partial Breast irradiation study
• RTOG IMRT studies
• RTOG 0232 Prostate Seed Permanent implant

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Frequently Asked Questions (7)

• Where do I find the forms?
• The Facility Questionnaire and DDSI form are
  found on the ATC website http//atc.wustl.edu
• These online forms require a user name and
  password. (The user name and password is not the
  same as for your FTP account.)
• You may call or email the ITC to receive the
  username and password for forms
• Username atc-forms
• Password submit

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DRY RUN TEST

• The Dry Run Test is intended to demonstrate
• Digital patient data exchange capability
• Understanding of protocol requirements
• Tumor/target volumes
• Critical structures
• Dose prescription
• Identical to an actual case for planning and
  submission excepting films and actual treatment.
• Moving to new paradigm

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Digital Data to Be Submitted to ITC

• Electronic digital data plan sent by SFTP or
  media
• DDSI online form
• Color isodosessent as JPEGs or mailed
• Email sent to ITC---study number, case ,
• benchmark, dryrun, why resubmitted,
  modality

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Items that need to be sent with Digital Data

• Digital Data Submission Information Form
• Filled out online on the ATC website
• Login atc-forms Password submit
• Color isodoses
• Color printouts express mail
• JPEG screen grabs FTP or email
• Email to ITC notifying case was submitted

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The Digital Data Submission Information (DDSI)
Form

• Documents digital data submitted to ITC
• Also provides information that can not be
  attained digitally
• Form found on ATC web site
• Should not be sent until digital submission has
  been accomplished
• Now only available as an online web form.

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Online form requires Login and password Login
atc-forms Password submit
Form will not be accepted unless critical fields
are filled in. These fields will be outlined in
red if they are not filled in properly.
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Frequently Asked Questions (8)

• Where do I get a Case Number ?
• Case numbers are assigned when a patient is
  registered or randomized with the cooperative
  study group.
• Case numbers are sent to data managers as part of
  registration/ randomization confirmations.
• Check with your research associate/data manager
  for case numbers.
• The NSABP B39/RTOG 0413 trial has a 9 digit
  number assigned for each case
• the first 2 numbers will be 79
• the next 4 are the case number
• The last 3 numbers are specific to the
  institution.
• Thus, 790165032 is case 0165.
• For credentialing submissions (dry-run,
  benchmark, phantom) there is no case number use
  dry, dryrun, benchmark, or phantom to
  identify data.

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Case Reviews for RTOG 0413

• Multi-faceted review process including PIs from
  protocol and their designates, Dosimetrists from
  RTOG and RPC, and ITC personnel.
• Three (3) Business Days are allowed for a Rapid
  Review Case (Case that requires approval prior to
  treatment start)

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Case and Credentialing Review

• If data is received and able to be reviewed the
  institution will not hear back from the ITC
• Need to allow 3 business days for Rapid Reviews
  (Reviews requiring approval prior to treatment).
• Approximately 50 of the rapid reviews require
  resubmission.
• Notification regarding rapid reviews will come
  from a PI or study chair

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ITC digital data submission reconfiguration

• PLEASE READ - Important Information for Protocol
  Participants Changes in Uploading Digital Data
  to ITC in May 2006
• Please see ATC website for configuration change.
  Changing data upload to a Secure FTP upload from
  the present non-secure upload.

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Frequently Asked Questions

• What do I send to the ITC?
• Digital treatment planning data sent by FTP or
  media
• DDSI online form
• Color isodoses emailed as JPEGs or express
  mailed
• Email sent to ITC, identifying protocol number,
  case number,
• whether benchmark or dryrun, why resubmitted,
  treatment modality
• Examples
• RTOG 0126 case 55
• RTOG 0413 mammosite benchmark
• RTOG 0225 Phantom,
• RTOG 0413 case 24 resubmitted with corrected
  contours.

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LABEL LABEL LABEL

• PLEASE remember to send the study number and
  case number or if the data is a Phantom, dryrun,
  benchmark when corresponding to the ITC.

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Problems with Data Identification

• What we get
• dcmcd
• dryrun----dry
• 975642
• IMRT
• 010506
• Smith
• dloJW00690051_552_I.tar
• What we need labels with study number, case,
  modality, e.g.,
• 0126_3Ddryrun
• 0413mammo
• 0225Phantom

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Where Do I Get More Info?

• ATCs Web Site
• http//atc.wustl.edu

These slides and handouts can be found here
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Contact ITC with Questions

• Use http//atc.wustl.edu for information about
  what, when, and how to submit data to the ITC.
• Contact information
• Roxana Haynes
• [phone]
• Bill Straube
• [phone]
• Anna Eccher
• [phone]
• email questions to itc_at_wustl.edu

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OPEN ADVANCED TECHNOLOGY STUDIES (JANUARY 2007)

• RTOG 0117
• RTOG 0126
• RTOG 0232
• RTOG 0413
• RTOG 0415
• RTOG 0418
• RTOG 0435
• RTOG 0438

• RTOG 0515
• RTOG 0521
• RTOG 0522
• RTOG 0529