QIBA vCT Lung Cancer Template (Editable)
UPICT template structure as modified by QIBA VolCT Technical Committee
June 25, 2009
The QIBA VolCT Technical Committee modified and used the UPICT template for a VolCT profile on CT Lung Nodule Volume Measurement for Primary/Regional Nodes and Metastatic Sites. The organizational structure, derived from the UPICT template and used by the VolCT group, is below.
The entire draft VolCT profile on CT Lung Nodule Volume Measurement in the modified UPICT template can be found on the QIBA Wiki at http://qibawiki.rsna.org/index.php?title=Profile:_CT_Lung_Nodule_Volume_Measurement_for_Primary/Regional_Nodes_and_Metastatic_Sites
Section 1: Title Page
- Version
- Acknowledgement
- Suggestion for attribution
- Table of Contents Page
Section 2: Executive Summary, Introduction and Background Information
Section 3: Imaging Protocol: Overview
- 3.1 Utilities and Endpoints of the Imaging Protocol within the Clinical Trial
- 3.2 Management of Pre-enrollment Imaging Tests
- 3.3 Timing of Imaging Tests within the Clinical Trial Calendar
- 3.4 Management of On-protocol Imaging Performed Off-schedule
- 3.5 Management of Off-protocol Imaging
- 3.6 Subject Selection Criteria Related to Imaging (mainly exclusionary in nature)
Section 4: Subject Preparation
- 4.1 Interval Timing (e.g., oral and/or IV intake, vigorous physical activity, timing relative to non-protocol-related medical interventions, etc.)
- 4.2 Specific Pre-imaging Instructions
- 4.2.1 Prior to Arrival
- 4.2.2 Upon Arrival (including ancillary testing associated with the imaging and downstream actions relative to such testing)
Section 5: Imaging Procedures: General
- 5.1 Imaging Agent Preparation and Specification (Contrast agent or radiopharmaceutical)
- 5.1.1 Contrast administration: (agent, dose, route)
- 5.1.2 Contrast Dose Reduction Based On Creatinine Clearance: (renal function)
- 5.2 Imaging Data Acquisition
- 5.2.1 Subject Positioning
- 5.2.2 Instructions to Subject during Acquisition (e.g., breathing)
- 5.2.3 Timing (e.g., relative to previously administered imaging agents / enhancers; inter-time point standardization)
Section 6: Universal Parameters (independent of vendor, platform, and version)
- 6.1 Devices
- 6.2 # of channels
- 6.3 Detail: Protocol retrieval
- 6.4 Detail: Anatomical Coverage
- 6.5 Detail: Slice Width
- 6.6 Detail: Slice interval
- 6.7 Detail: Isotropic Voxels
- 6.8 Detail: Field of View: Voxel Size
- 6.9 Detail: Scan Plane
- 6.10 Detail: Motion Artifact
- 6.11 Detail: Noise Level
- 6.12 Detail: Noise
- 6.13 Detail: Spatial Resolution
- 6.14 Detail: KVP
- 6.15 effective mAs (medium patient)
- 6.16 Detail: Rotation Speed
- 6.17 Detail: Collimation width (total nominal beam width - often not specified on scanner interface)
- 6.18 Detail: Mode
- 6.19 Detail: Table speed
Section 7: Specific Parameters (vendor, platform, and/or version-dependent) May be contained in associated tables
- 7.1 Hardware and Set-up
- 7.2 Software (if appropriate, provide as electronic file for direct implementation on to the imaging platform if appropriate)
Section 8: Inherent Image Data Reconstruction / Processing
(e.g., data correction, smoothing)
- 8.1 Reconstruction Kernel Characteristics
- 8.2 Reconstruction Interval
- 8.3 Reconstruction Interval Overlap
Section 9: Archival Requirements for Primary Source Imaging Data
- 9.1 Detail: Data should be archived in DICOM 3.0 format or the current version of DICOM recommended by XXX WG YY of the XXX.
- 9.2 De-identification / Anonymization Schema(s) to Be Used
- 9.3 Archival and Transmission of Image Data
- 9.4 Requirements for Local Retention of Imaging Data
:9.5 Requirements for Central Management of Imaging Data and Imaging Metadata (e.g., the results of image analysis)
Section 10: Post-processing
(i.e., anything not done on an acquisition platform that affects DICOM image data and/or pixel / voxel values)
None prior to importation into free standing image analysis software package (Editor’s note: The analyses on the free-standing image analysis software package or independent workstation is the content intended for Section 10)
Appendices
Appendix 1. Definitions of Terms and Abbreviations
Appendix 2. Acquisition Parameters and Settings for Specific Makes, Models, and Software Versions
Appendix 3. Imaging-associated Risks and Risk Management
Appendix 4. Reader Training
Appendix 5. Site Selection, Qualification and Protocol-specific Training
Appendix 1. Definitions of Terms and Abbreviations
Appendix 2. Acquisition Parameters and Settings for Specific Makes, Models and Software Versions Appendix 3. Imaging-associated Risks and Risk Management
- A3.1 Radiation Dose and Safety Considerations
- A3. 2 Imaging Agent Dose and Safety Considerations
- A3.3 Imaging Hardware-specific Safety Considerations
Appendix 4. Reader Training Appendix 5. Site Selection, Qualification and Protocol-specific Training
- A5.1 Necessary Site Characteristics (e.g., support infrastructure, internet capability, image de-identification and transmission capability)
- A5.2 Personnel
- A5.2.1 Qualifications
- A5.2.1.1 Technical
- A5.2.1.2 Physics
- A5.2.1.3 Physician
- A5.2.2 Protocol-specific Training
- A5.2.2.1 Technical
- A5.2.2.2 Physics
- A5.2.2.3 Physician
- A5.3 Availability of Relevant Imaging Equipment
- A5.4 Baseline Quality Control Metrics and Capability for Quality Control Procedures (Pertinent to the Clinical Trial)
Quality Control (QC)
QC.1 Quality Control Associated with Individual Subject Imaging
Activity: Acquisition System Calibration
- QC.1.1 Phantom Imaging and/or Calibration
- QC.1.2 Quality Control of the Subject Image and Image Data
- QC.1.3 Documentation of Phantom Imaging and Calibration
- QC.2 Quality Control Associated with Imaging Agent Administration
- QC.3 Management and Reporting of Adverse Events Associated with Imaging Agent and Enhancer Administration
- QC.4 Management and Reporting of Adverse Events Associated with Image Data Acquisition
- QC.5 Quality Control of Inherent Image Data Reconstruction / Processing
- QC.5.1 Universal
- QC.5.2 Vendor-, Platform- and/or Version-specific
- QC.6 Quality Control of Image Analysis and Interpretation
- QC.7 Site-Related Quality Control
- QC.7.1 Mandatory for Site-Selection (e.g., routine and periodic QC measures and documentation)
- QC.7.2 Mandatory to Submit Prior to Patient Accrual
- QC.7.3 Mandatory to Submit Periodically During the Trial
Required Documentation (RD)
- RD .1 Subject preparation
- RD .2 Imaging agent dose calculation
- RD .3 Imaging agent-related
- RD .4 Image data acquisition-related
- RD .5 Inherent image data reconstruction / processing
- RD .6 Image analysis and interpretation
- RD .7 Site selection and Quality Control