1. Synta Pharmaceuticals Protocol 9090-08 The GALAXY Study
Investigator Meeting
BioClinica, Inc.
Bio-Imaging Technologies, Inc.

2. Agenda Imaging Objectives Start-Up Procedures
Imaging Data Procedures at Sites
Imaging Data Procedures at BioClinica
BioClinica Responsibilities
Site Responsibilities
Imaging FAQs and Challenges
Bio-Imaging Technologies, Inc.

3. Imaging Objectives High Quality Adherence to Imaging Guidelines
Consistency in Data Acquisition
Completed and Signed Data Transmittal Forms
Submittal of Data within 5 Business Days
Proactivity in Notifying BioClinica of Imaging Issues/Delays
Bio-Imaging Technologies, Inc.

4. Start Up Procedures: Site Surveys and Study Kits
Purpose
establishing communication
identifying contact information for operative site personnel
reviewing imaging equipment, and software archival capabilities
identifying site-preferred media
Completed by Study Coordinator or Other Site Designee
3 Site Survey Follow Ups
Bio-Imaging Technologies, Inc.

5. Start Up Procedures: Site Surveys and Study Kits
BioClinica Team Contact Information
Imaging Binder for Storage of Study-Related Forms and Documents
Imaging and Submission Guidelines
General Principles for Submitting Film Data
Frequently Asked Questions (FAQs)
Quick Reference Guides (QRG)
Digital Archival Media (Pre-Labeled)
Film Labels
Black Paint Pens
Data Transmittal Forms
Sample Forms
Pre-Addressed Courier Air Waybills
Re-Order Supply Form
Mailer Envelopes
Bio-Imaging Technologies, Inc.

6. Standardization and Consistency
Data Acquisition (Across sites and Timepoints)
Equipment
Parameters
Slice Thickness
Ensures consistency in the evaluation of study endpoints
Bio-Imaging Technologies, Inc.

7. Imaging
Whole Body Bone Scan, Screening, Q12 Weeks for Subjects with Bony Lesion at Screening, and/or where Clinically Indicated)
Contrast Enhanced CT is the Preferred Modality
Chest
Upper Abdomen
MRI is the Preferred Modality for the Brain (at Screening and at Follow Up time points as clinically
PET/CT scanners may be used to acquire the above required CT scans if of diagnostic quality, but fused PET/CT images are not acceptable
Non-Contrast CT of Chest and MRI of the Brain and Abdomen is recommended for Subjects with Contraindication to IV Contrast
PET (must be performed prior to CT with IV contrast)
Bio-Imaging Technologies, Inc.

8. PET/CT Some PET scanners can be used to acquire a CT scan
Fused CT/PET scans are not acceptable
BioClinica cannot separate a fused CT/PET scan
A CT acquired with a PET scanner is acceptable. To obtain optimal quality comparable to diagnostic CT, please adhere to the following:
Oral and IV contrast
Slice thickness of 3-5 mm preferred
Patient positioning
Consistency across timepoints for a subject is key
Same machine should be used
Anatomy should be consistent
Bio-Imaging Technologies, Inc.

9. CT Anatomic Coverage Brain (Baseline and as clinically indicated)
Cranial Vertex through Occiput
Chest and Abdomen
Above lung apices to below illiac crest (to include liver)
Bio-Imaging Technologies, Inc.

10. MRI Anatomical Coverage
MRI of Brain (Screening and as Clinically Indicated)
Foremen magnum through vertex of skull
MRI of Abdomen
Above diaphragm through liver to iliac crest
Non-contrast CT of Chest
Diaphragm through liver to iliac crest
Bio-Imaging Technologies, Inc.

11. Image Submission Procedure
Image Data to BioClinica Within 5 Working Days
Quick Image Submission Permits the Detection and Correction of Problems Early On
Digital Data is Preferred
WebSend
DICOM
Film Data is Acceptable
Complete Set of Films
All Data Should Be Clean – No Marking
Data Transmittal Forms
Bio-Imaging Technologies, Inc.

12. WebSend
Web-based solution for expediting the sharing, tracking, archiving and analysis of medical images for multi-center clinical trials with imaging endpoints
Protects patient confidentiality by automatically masking PHI
Quick and easy implementation
Automates the image tracking process
Provides complete audit trail with time & date stamps
Sites receive confirmation of image receipt
All image data is electronically backed-up and secure

13. Data Transmittal Form Must be Completed for Each Patient/Timepoint
Site Retains Copy in Imaging Binder
Submit Original with Image(s)
Provides BioClinica with Information Vital to QC and Tracking of Data
Site & Patient Identification
Imaging Time Point
Technical Information
Imaging Parameters
The identifiers (CRF number and exam date) on the DTF and CD labels must match the scan date imbedded in the data – NOT the study visit date. If you are unsure of the technical information required for the DTF, please ask your radiology department for assistance at the time they perform the imaging.
Bio-Imaging Technologies, Inc.

14. CD and Film Labels CD Labels Film Labels
Pre-Printed with Synta Protocol Number and BioClinica Assigned Project Code
Sites Complete Fields for:
Site Number/PI Name
Patient number/Initials
Imaging time point
Date of scan
Film Labels
Labels must be affixed to each film submitted.
Bio-Imaging Technologies, Inc.

15. Courier Waybills Pre-Printed
Pre-Addressed with BioClinica as Recipient
Contains a Unique Project Code (used by BioClinica)
Only Sender Information Needs to be Completed by the Site
Bio-Imaging Technologies, Inc.

16. Data Quality Analysis/Quality Control
Data Collection
Data Log-In/Tracking
DTF against Data
Translation/Digitization
Review Process
Technical Adequacy
Protocol Compliance
DCF if needed
BioClinica will provide confirmation of image quality for screening scabs prior to randomization of subjects
Bio-Imaging Technologies, Inc.

17. Communication Methods to Sites
Data Clarification Forms
Quality Issues, Missing Anatomy, Unacceptable Formatting, etc.
Require a Response (5 Business Days)
Quality Notification Forms
Do Not Require a Response
Site Data Summary Reports
Outstanding Scans
Outstanding Data Clarification Forms
Outstanding Surveys
Upcoming Scans
Bio-Imaging Technologies, Inc.

18. Data Clarification Forms
Generated by BioClinica
Requires a Site Response
Must Be Returned Within 1 Week
Reasons for DCF(s)
Discrepancies
Missing Anatomy
Missing DTF(s)
Quality Issues
Bio-Imaging Technologies, Inc.

19. BioClinica Responsibilities
Provide Site Survey
Provide Imaging Kit
Collect Image Data
Quality Control
Follow-Ups on Outstanding Surveys and Data
Address Site Requests and Concerns
Bio-Imaging Technologies, Inc.

20. Site Responsibilities
Site Survey Completion
Alert Site Personnel to Imaging Requirements
Acquire Protocol-Compliant Imaging
Proper Labeling of Imaging and Films
Completion of Data Transmittal Films
Submittal of Data within 5 Business Days
Prompt Response to Data Clarification Forms
Bio-Imaging Technologies, Inc.

21. Frequently Asked Questions (1 of 2)
Q: Whom should I contact if I have questions about acquiring data per Protocol?
A: Your 1st line of contact should be the BioClinica Project Manager. Alternately, the Help Desk is available 24/7.
Q: How Can I Acquire More Supplies
A: Complete and fax a supply order form, the supplies contact, or contact the Project Manager
Q: Our site has already been contacted by BioClinica about Outstanding Survey information. Why have we been contacted again?
A: BioClinica will follow up with sites 3 times for outstanding Surveys.
Bio-Imaging Technologies, Inc.

22. Frequently Asked Questions (2 of 2)
Q: Why is it necessary to acquire all images at 5mm?
Acquiring images at thicker slices could cause the independent radiologists to miss critical anatomy.
Q: In which format should data be submitted?
A: All data should be submitted in uncompressed DICOM data.
Q: Our site would like data returned. Is this a problem?
A: Film data will be returned following digitization at BioClinica. Copies of digital data should be submitted to BioClinica, to be returned at the study’s end. Should original data be submitted to BioClinica before a copy is made at the site, please contact the Project Manager. BioClinica will make a copy and return the original data.
Q: Why is it necessary to inform BioClinica of scheduled scans that have not been performed?
A: Un-Acquired scans will need to be removed from any reports/ follow ups detailing Outstanding Data.
Bio-Imaging Technologies, Inc.

23. Contact Information
Cristen Kelleher
Project Manager
Tel:
Fax:
BioClinica Supplies
Tel:
Fax:
HelpDesk
Toll-Free (US and Canada):
1-888-ASK-BIO2 ( )
Bio-Imaging Technologies, Inc.