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PRIMA Investigator‘s Meeting
Protocol MO18264
ASH 2006
Bio-Imaging Technologies, Inc.
December 9th, 2006
Agenda
• Bio-Imaging Overview
• Role of Bio-Imaging
• Imaging Requirements
• Bio-Imaging Responsibilities
• Site Responsibilities
Bio-Imaging Overview
• Imaging Core Lab
– Standardization of Imaging
– Collection and QC of Image Data
– Independent Review of Image Data
• State-of-the-Art, FDA Compliant
Centralized Core Labs
– Newtown, PA
– Leiden, The Netherlands
• 269 Employees
– 201 USA
– 68 Leiden
Role of Bio-Imaging
• Obtain High Quality Standardized Image Data
– Standardized Imaging Protocol
› Ensures Consistent Acquisition Across All Clinical Sites
and Imaging Timepoints
• Standardized Procedure to Submit Image Data
• Provides Image Data in Standard Format
• Perform Independent Blinded Review
• Maximize Power of Image Data
Study MO18264 (PRIMA)
• Imaging Endpoints
– Progression Free Survival from maintenance
randomization (PFS) defined as the time from
randomization to progression, relapse, or death
from any cause.
Imaging Requirements
• Timepoints
– Baseline
– Induction
– Maintenance
– End of Treatment
– Follow-up
• Anatomical Region
– Chest, Abdomen, Pelvis
Imaging Requirements
• Scans Must be Performed Consistently Between
All Timepoints to Assess Endpoints
• Same Scanner & Technique Must be Used
Throughout the Trial
Retrospective Data Collection
• Retrospective Study Kit
– Instructional Letter
– Contains basic instructions
– Retrospective Data Transmittal Forms (rDTF)
– Film Labels
– Pre-addressed Waybills
– Supply Reorder Forms
– Envelopes/Padded Mailers
– Paint pens
– Used for blinding films
Retrospective
Data Transmittal Forms (rDTF)
• rDTF can be completed by Monitors, CRA’s or
site
• Multiple patients (3) can be listed on one rDTF
• Each retrospective timepoint must be
accompanied with an rDTF.
Image Submission Procedure
(Retrospective)
• Provide Complete Image Data Set
– Film or Digital Data Must be Submitted
– Include Retrospective Data Transmittal Form
– Ship all data to Bio-Imaging using the provided
envelopes/padded mailers and pre-addressed
Waybills
• All Retrospective data should be sent to our
Newtown Office
Imaging Study Kit
• Imaging Study Kit (for prospective data)
– Imaging Guidelines
– Includes blinding instructions
– Image Data/Archival Transmittal Instructions
– Data Transmittal Forms
– Pre-addressed Waybills
– Supply Reorder Forms
– Paint Pens
– Image Archival Media
 Optical Disks, Tapes, CDs
Imaging Guidelines
• Provide Detailed Imaging Requirements
– Sets Standards for Proper Image Acquisition
– Defines Timepoints for Imaging
– Sample Images, Both Correct and Incorrect
– Blinding
– Shipment of Images
– Bio-Imaging Contact Information
• Important for Radiology Technologists to
Read and Understand Guidelines
Image Submission Procedure
(Prospective)
• Provide Complete Image Data Set
–
–
–
–
After Each Timepoint
Submit Within 2 - 5 Days of Scan
Digital Data Must be Submitted
Include Data Transmittal Form
Blinding/Masking Procedures
Film and Digital
• Blinding Film Data
– Black paint pen are provided to blind/mask sensitive data
– Do not place tapes or stickers on the films.
› Only use labels provided by Bio-Imaging
› Do not place labels over the imaging parameters on the film.
• Blinding Digital Data
– Digital data should be anonymized (masked) prior to
archiving, by utilizing the study specific Investigator Number,
Patient Number and Patient Initials.
Blinding/Masking Procedures
(continued)
• Bio-Imaging will strictly maintain patient
confidentiality at all times.
• In the event that unmasked data is
unintentionally submitted, Bio-Imaging will
remove patient identifiers.
– A Quality Notification Form (QNF) will be forwarded to
the site
Image Data Flow
Transmit
Initial QC
Log/Track
Digitize or
Translate
Site
Site
Preparation
&
Standardization
Independent Review
Image QC & Archival
Data Transmittal Form
• Provides Bio-Imaging with Vital Information
to QC and Track Image Data
– Site and Patient Identification
– Imaging Timepoint Information
– Imaging Parameter Information
•
•
•
•
Must be Completed for Each Timepoint
Submit with Image Data
Three (3) Part NCR Form
Site Retains Pink Copy
Media
• A Media Label Must be Present on All Image
Data Submitted to Bio-Imaging
• Digital Media will be Supplied with an Attached
Pre-Printed Label but Needs to be Completed
by Site
Courier Waybills
• Provided With Pre-printed Courier Waybills
• Pre-addressed With Bio-Imaging as Recipient
• Sites Must Complete Sender Information
• Contains a Unique Project
Code
– Bio-Imaging specific
Central Image Collection
• Data Collection
– Coordinate
– Log and Track
• Initial QC of Image Data
– Preliminary Check
– Image Data Clarifications
• Image Data Tracking
Image QA/QC Review
• Performed by Radiology Technologist
• Protocol Compliance
• Technical Adequacy
• Rapid Review Process
– Detect Problems Early
– Prevent Backend Delays
Communication To Sites On Quality
• Data Clarification Form (DCF)
– Query Regarding
› Imaging Data Received
› Data Transmittal Form (DTF)
• Quality Notification Form (QNF)
– Notice on Quality of Imaging
› Identify Improvements Needed for Future Imaging
Image Data Clarification Form
• Generated by Bio-Imaging
• Requires a Site Response
• Must be Returned within 1 Week
of Issuance of Original DCF Form
Reasons For Queries
• Missing Demographic Information on DTF
– Patient registration #, Patient initials, etc…
• Mismatch Between DTF and Digital Media/Films
• Site Not Consistent with Imaging Parameters Between
Timepoints
•
•
•
•
Clarification of Information
Missing Image Data
Missing Forms (DTF)
Repeat Scans (Quality Issues)
How To Ensure Quality At Your Site
• Establish Communication with Radiology Department
• Communicate Regularly With Radiology Department
• Schedule Patients in a Timely Manner
• Ensure CT Scan Consistency
• Timely Submission of Images to Bio-Imaging
Site Responsibilities
• Notify Radiology Dep. of Imaging Requirements
• Perform Protocol Compliant Imaging
• Proper Labeling of Image Data
• Completion of Data Transmittal Form
• Timely Submission of Image Data
• Prompt Response to Data Clarification Form
Bio-Imaging Responsibilities
• Send Imaging Study Kit
• Collect Image Data
• Quality Control of Image Data
• Follow-up on Image Data Clarifications
• Analyzing/Reviewing Imaging Data
• Export Analysis to Roche
Contact Information
Bio-Imaging Technologies, Inc.
826 Newtown-Yardley Road
Newtown, PA 18940-1721
Tel: +1.267.757.3000
Tel: +1.800.748.9032
Fax: +1.267.757.1361
Bio-Imaging Supplies
Tel: +1.267.757.3002
Fax: +1.267.757.1380
Email: supplies@bioimaging.com
Web Address:
www.bioimaging.com