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

• 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

Role of Bio-Imaging

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 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 Collection

RetrospectiveData 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.

• 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

Image Submission Procedure(Retrospective)

• 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 Study Kit

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

• Provide Complete Image Data Set– After Each Timepoint

– Submit Within 2 - 5 Days of Scan

– Digital Data Must be Submitted

– Include Data Transmittal Form

Image Submission Procedure(Prospective)

• 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 ProceduresFilm and Digital

• 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

Blinding/Masking Procedures(continued)

Image Data Flow

Initial QC

Digitize or Translate

Transmit

Log/Track

Site

Image QC & Archival

Independent Review Site Preparation

&Standardization

• 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

Data Transmittal Form

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

• 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

Courier Waybills

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

• Generated by Bio-Imaging

• Requires a Site Response

• Must be Returned within 1 Week

of Issuance of Original DCF Form

Image Data Clarification 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

Bio-Imaging Technologies, Inc.826 Newtown-Yardley RoadNewtown, PA 18940-1721Tel: +1.267.757.3000Tel: +1.800.748.9032Fax: +1.267.757.1361

Bio-Imaging SuppliesTel: +1.267.757.3002Fax: +1.267.757.1380Email: supplies@bioimaging.com

Web Address:www.bioimaging.com

Contact Information