1. AMERICAN COLLEGE OF RADIOLOGY March 23, 2006

2. http://upict.acr.org OUR MISSION To foster the ongoing development of widely acceptable consistent imaging protocols and quality control procedures across the multiple sites and modalities needed for case accrual and statistical power through the expertise and participation of radiologists, radiation oncologists, nuclear medicine physicians, other medical specialists, medical physicists, clinical trial experts and industry. American College of Radiology

3. Rationale Uniform protocols that can be used in assessing efficacy in therapeutic trials are also of great interest both to trialists and to industry for accelerating drug development process.

4. To address the needs of all affected parties, it is evident that imaging acquisition standards must: account for variations in technology currently being used provide sufficient detail with regard to format, structure, and implementation to ensure consistency and reproducibility across platforms and clinical sites reasonably accommodate imaging procedures in the context of usual care acknowledge rapid evolution/progress of technology and incorporate change management while providing periods of stability (measured in a specified number of years) through predictable/announced version control acknowledge/reference the needs and responsibilities of governmental granting agencies supporting clinical trials (e.g.: NCI/CTEP/CIP) and regulatory agencies (e.g.: FDA) be used to establish consistency in clinical trials and should not dictate the practice of medicine outside the appropriate clinical trials

5. UPICT Template Uniform Protocol for of the 1.Goal/Objective of Imaging 2.Responsibilities of CRO or Imaging Core Laboratory 3.Reader Selection 4.Platform/Equipment Specification 5.Image Data Acquisition 6.Frequency of Imaging

6. UPICT Template 7. Image Quality at Imaging Site 8. Reading environment and image presentation 9.Workstation/ Viewing Conditions 10. Interpretation 11. Equipment data considered for specification: –CT; example parameters: –MRI; example parameters: –Radiography; example parameters: –PET scanners; example parameters: –PET/CT scanners: example parameters 12. More detailed technique data considerations

7. UPICT Representatives American College of Radiology Food & Drug Administration National Cancer Institute Radiological Society of North America Society of Nuclear Medicine American Association of Physicists in Medicine American Society of Clinical Oncology National Electrical Manufacturers Association American College of Radiology Imaging Network Radiation Therapy Oncology Group

8. End