Title: AMERICAN COLLEGE OF RADIOLOGY
1AMERICAN COLLEGE OF RADIOLOGY
March 23, 2006
2http//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.
3Rationale
- 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.
4To 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
5UPICT Template
- Uniform Protocol for ltmodalitygt of the ltbody part
and/or disease entitygt - Goal/Objective of Imaging
- Responsibilities of CRO or Imaging Core
Laboratory - Reader Selection
- Platform/Equipment Specification
- Image Data Acquisition
- Frequency of Imaging
6UPICT Template
- 7. Image Quality at Imaging Site
- 8. Reading environment and image presentation
- Workstation/ Viewing Conditions
- 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
7UPICT 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
8End