NEMA Standards Publication NU Performance Measurements of Positron Emission Tomographs (PETS)

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NEMA Standards Publication NU 2-2018 Performance Measurements of Positron Emission Tomographs (PETS) Published by: National Electrical Manufacturers Association 1300 N. 17 th Street, Suite 900 Rosslyn, VA 22209 www.nema.org All rights including translation into other languages, reserved under the Universal Copyright Convention, the Berne Convention for the Protection of Literary and Artistic Works, and the International and Pan American Copyright Convention.

NOTICE AND DISCLAIMER The information in this publication was considered technically sound by the consensus of persons engaged in the development and approval of the document at the time it was developed. Consensus does not necessarily mean that there is unanimous agreement among every person participating in the development of this document. The National Electrical Manufacturers Association (NEMA) standards and guideline publications, of which the document contained herein is one, are developed through a voluntary consensus standards development process. This process brings together volunteers and/or seeks out the views of persons who have an interest in the topic covered by this publication. While NEMA administers the process and establishes rules to promote fairness in the development of consensus, it does not write the document and it does not independently test, evaluate, or verify the accuracy or completeness of any information or the soundness of any judgments contained in its standards and guideline publications. NEMA disclaims liability for any personal injury, property, or other damages of any nature whatsoever, whether special, indirect, consequential, or compensatory, directly or indirectly resulting from the publication, use of, application, or reliance on this document. NEMA disclaims and makes no guaranty or warranty, express or implied, as to the accuracy or completeness of any information published herein, and disclaims and makes no warranty that the information in this document will fulfill any of your particular purposes or needs. NEMA does not undertake to guarantee the performance of any individual manufacturer or seller s products or services by virtue of this standard or guide. In publishing and making this document available, NEMA is not undertaking to render professional or other services for or on behalf of any person or entity, nor is NEMA undertaking to perform any duty owed by any person or entity to someone else. Anyone using this document should rely on his or her own independent judgment or, as appropriate, seek the advice of a competent professional in determining the exercise of reasonable care in any given circumstances. Information and other standards on the topic covered by this publication may be available from other sources, which the user may wish to consult for additional views or information not covered by this publication. NEMA has no power, nor does it undertake to police or enforce compliance with the contents of this document. NEMA does not certify, test, or inspect products, designs, or installations for safety or health purposes. Any certification or other statement of compliance with any health or safety related information in this document shall not be attributable to NEMA and is solely the responsibility of the certifier or maker of the statement.

Page i CONTENTS Foreword... iv Section 1 Definitions, Symbols, and Referenced Publications... 1 1.1 Definitions... 1 1.2 Standard Symbols... 1 1.3 Referenced Publications... 3 Section 2 General... 4 2.1 Purpose... 4 2.2 Purview... 4 2.3 Units of Measure... 5 2.4 Consistency... 5 2.5 Equivalency... 5 Section 3 Spatial Resolution... 7 3.1 General... 7 3.2 Purpose... 7 3.3 Method... 7 3.3.1 Radionuclide... 7 3.3.2 Source Distribution... 7 3.3.3 Data Collection... 8 3.3.4 Data Processing... 8 3.4 Analysis... 8 3.5 Report... 9 Section 4 Scatter Fraction, Count Losses, and Randoms... 10 4.1 General... 10 4.2 Purpose... 10 4.3 Method... 10 4.3.1 Symbols... 11 4.3.2 Radionuclide... 11 4.3.3 Source Distribution... 11 4.3.4 Data Collection... 12 4.3.5 Data Processing... 12 4.4 Analysis... 13 4.4.1 Analysis with Randoms Estimate... 14 4.4.2 Alternative Analysis with No Randoms Estimate... 15 4.5 Report... 16 4.5.1 Count Rate Plot... 16 4.5.2 Peak Count Values... 16 4.5.3 System Scatter Fraction... 16 4.5.4 Table and Phantom Positioning, and Projection Alignment... 16 Section 5 Sensitivity... 17 5.1 General... 17 5.2 Purpose... 17 5.3 Method... 17 5.3.1 Symbols... 17 5.3.2 Radionuclide... 17 5.3.3 Source Distribution... 18 5.3.4 Data Collection... 18 5.4 Calculations and Analysis... 18 5.4.1 System Sensitivity... 18 5.4.2 Axial Sensitivity Profile... 19 5.5 Report... 19

Page ii Section 6 Accuracy: Corrections for Count Losses and Randoms... 21 6.1 General... 21 6.2 Purpose... 21 6.3 Method... 21 6.3.1 Symbols... 21 6.3.2 Radionuclide... 21 6.3.3 Source Distribution... 21 6.3.4 Data Collection... 21 6.3.5 Data Processing... 21 6.4 Analysis... 21 6.5 Report... 22 Section 7 Image Quality, Accuracy of Corrections... 23 7.1 General... 23 7.2 Purpose... 23 7.3 Method... 23 7.3.1 Symbols... 23 7.3.2 Radionuclide... 23 7.3.3 Source Distribution... 24 7.3.4 Data Collection... 24 7.3.5 Data Processing... 25 7.4 Analysis... 25 7.4.1 Image Quality... 25 7.4.2 Accuracy of Corrections... 26 7.5 Report... 26 Section 8 Time-of-Flight Resolution... 30 8.1 General... 30 8.2 Purpose... 30 8.3 Method... 30 8.3.1 Symbols... 30 8.3.2 Radionuclide... 31 8.3.3 Source Distribution... 31 8.3.4 Data Collection... 31 8.3.5 Data Processing... 31 8.4 Analysis... 32 8.4.1 2-D Histogram formation... 32 8.4.2 Scatter and Random Removal... 33 8.4.3 FWHM Analysis... 33 8.5 Report... 33 Section 9 PET-CT Coregistration Accuracy... 35 9.1 General... 35 9.2 Purpose... 35 9.3 Method... 35 9.3.1 PET-CT Fiducial Marker... 35 9.3.2 Fiducial Marker and Mass Distribution... 35 9.3.3 Data Collection... 36 9.3.4 Data Processing... 37 9.4 Analysis... 37 9.4.1 PET and CT Image Fusion... 37 9.4.2 Processing of Data... 37 9.4.3 Location of Maximum Voxel Value in the PET and CT Data... 37 9.4.4 Dimensions of the Volume Used in the Calculation of the Centroid... 38 9.4.5 PET and CT Centroids... 39 9.4.6 Verification of Fiducial Marker Dimension and Pixel Size... 39

Page iii 9.4.7 Coregistration Error... 40 9.5 Report... 41

Page iv Foreword Reason for Changes NEMA requires that its standards be reviewed and, if necessary, updated every five years. This standards publication was developed by the NU 2 Task Force chartered by the Molecular Imaging Section of MITA. Committee approval of the standard does not necessarily imply that all committee members voted for its approval or participated in its development. The task force was composed of the following members: Yanic Bercier Siemens Healthineers, Knoxville, TN Michael A. Miller Philips, Highland Heights, OH Charles W. Stearns GE Healthcare, Waukesha, WI Jeffrey Kolthammer Canon Medical, Vernon Hills, IL In the preparation of this standards publication, input of users and other interested parties has been sought and evaluated. Inquiries, comments, and proposed or recommended revisions should be submitted to the concerned NEMA product section by contacting the: Senior Technical Director, Operations National Electrical Manufacturers Association 1300 North 17 th Street, Suite 900 Rosslyn, Virginia 22209 Changes to Tests The changes made by the Task Force from the 2012 version of this standard include the addition of two new sections: a. Section 8, to assess the coincidence timing resolution of tome-of-flight PET systems, and b. Section 9, to assess the co-registration accuracy of hybrid PET/CT systems. Other changes to the current version are relatively minor, mostly designed to make the tests easier to conduct, more reproducible, more clearly defined, or better harmonized with other performance tests. These are the most substantial changes to the tests (note that this is not intended to be an exhaustive list): a. In Section 3, the spatial resolution test allows 22 Na as well as 18 F. b. In Section 3, the spatial resolution test point source is specified in terms of point source dimensions as opposed to capillary tube dimensions. The capillary tube is specified as an option. c. In Section 4 (and in Section 6 and Section 8, which use the same acquired data), the test phantom is to be positioned so that the trough of the table is positioned 15 ±1 cm below the center of the transverse field of view (FOV). d. In Section 6, the analysis is to be conducted over the central 80% of the PET axial FOV. e. In Section 7, the 28 mm and 37 mm diameter cold spheres are replaced with 28 mm and 37 mm diameter hot spheres. All six spheres are to be hot. f. In Section 7, there is no option for a hot sphere-to-background fill ratio of 8:1. g. In Section 7, the lung residual error analysis excludes slices that are within 30 mm of the axial edge of the lung insert; the previous value was 10 mm. h. In Section 7, the description of phantom positioning is clarified. If the patient table cannot center the body phantom lung insert, adjust the patient table height to center the phantom as closely as possible. The phantom shall not be elevated above the patient table surface in order to center the phantom lung insert.

Page v Scope The philosophy and rationale of the standards measurements and illustrative examples of the analysis and results are presented in Journal of Nuclear Medicine, vol. 43, no. 10, 2002. Daube-Witherspoon ME, Karp JS, Casey ME, DiFilippo FP, Hines H, Muehllehner G, Simcic V, Stearns CW, Adam L-E, Kohlmyer S and Sossi V. PET Performance Measurements Using the NEMA NU 2-2001 Standard. pp. 1398-1409. With the exceptions of Section 8 for time-of-flight systems and Section 9 for hybrid PET/CT systems, the Task Force has attempted to specify methods that can be performed on all positron emission tomographs. These include single and multiple slice, discrete and continuous detector, time-of-flight instruments, multi-planar and volume reconstruction models, and dedicated positron emission tomographs as well as other coincidence-capable imaging systems. Wherever possible, future developments that could be readily anticipated were taken into account. While many PET tomographs are constructed as hybrid imaging systems such as PET/CT and PET/MR systems, the standards committee has not specified special methods to assess hybrid imaging performance with the exception of the PET/CT registration test described in Section 9. It is expected that the PET component of a hybrid imaging system can be assessed using the methods described in this standard, and other portions of the system can be assessed using other standards appropriate to that technology. The method for assessing the co-registration accuracy of hybrid PET/CT systems has the potential to be adapted to PET/MR systems. In the event a portion of any of the PET test methods described here cannot be executed in a hybrid imaging system, workaround methods may be used, but those methods must be described in the test report.