NEMA NU 3-2004 Performance Measurements and Quality Control Guidelines for Non-Imaging Intraoperative Gamma Probes《非镜像手术伽马探测器性能测量及质量控制指南》.pdf

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1、NEMA Standards PublicationNational Electrical Manufacturers AssociationNEMA NU 3-2004Performance Measurements and Quality Control Guidelines for Non-Imaging Intraoperative Gamma ProbesNEMA Standards Publication NU 3-2004 Performance Measurements and Quality Control Guidelines for Non-Imaging Intraop

2、erative Gamma Probes Published by: National Electrical Manufacturers Association 1300 North 17th Street, Suite 1847 Rosslyn, Virginia 22209 www.nema.org Copyright 2004 by the National Electrical Manufacturers Association. All rights including translation into other languages, reserved under the Univ

3、ersal Copyright Convention, the Berne Convention for the Protection of Literary and Artistic Works, and the International and Pan American Copyright Conventions. NOTICE AND DISCLAIMER The information in this publication was considered technically sound by the consensus of persons engaged in the deve

4、lopment 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

5、, 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

6、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. N

7、EMA 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 guara

8、nty or warranty, expressed 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

9、individual manufacturer or sellers 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 b

10、y 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 topi

11、c 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 certif

12、y, test, or inspect products, designs, or installations for safety or health purposes. Any certification or other statement of compliance with any health or safetyrelated information in this document shall not be attributable to NEMA and is solely the responsibility of the certifier or maker of the

13、statement. NU 3-2004 Page i Copyright 2004 by the National Electrical Manufacturers Association. CONTENTS Page Foreword .iv Section 1 PURPOSE, SCOPE, AND RATIONALE 1.1 Purpose. 1 1.2 Scope 1 1.3 Introduction . 1 1.3.1 Applications 2 1.3.2 Basic Probe Design . 3 1.4 Rationale for Non-imaging Intraope

14、rative Gamma Probe Measurements 3 1.4.1 Rationale for Sensitivity and Spatial Resolution Measurements . 3 1.4.2 Rationale for Sensitivity to Scatter Measurements 4 1.4.3 Rationale for Sensitivity to Distributed Activity in Water Measurements . 4 1.4.4 Rationale for Short-Term Sensitivity Stability i

15、n Air Measurements 4 1.4.5 Rationale for Count-Rate Capability with Scatter Measurement . 4 1.4.6 Rationale for Energy Resolution Measurement. 5 1.4.7 Rationale for Side and Back Shielding Measurement . 5 1.4.8 Probe Response Time . 5 1.4.9 Rationale for Radioisotope Used for Testing. 5 Section 2 RE

16、FERENCED PUBLICATIONS, DEFINITIONS, AND TEST EQUIPMENT 2.1 References 7 2.2 General Definitions 7 2.3 Terminology 9 2.4 Test Equipment, Conditions, and Results. 9 2.4.1 Source Holders and Test Fixtures . 9 2.4.2 Radiation Sources 9 2.4.3 Equipment Setup and Test Conditions 10 2.4.4 Reporting 11 2.4.

17、5 Measurements . 11 Section 3 PERFORMANCE MEASUREMENT TESTS 3.1 Sensitivity in Air. 12 3.1.1 Test Conditions 12 3.1.2 Measurement Procedure . 12 3.1.3 Calculations and Analysis 12 3.1.4 Reporting 12 3.2 Sensitivity in a Scatter Medium. 13 3.2.1 Test Conditions 13 3.2.2 Measurement Procedure . 13 3.2

18、.3 Calculations and Analysis 13 3.2.4 Reporting 13 3.3 Sensitivity through Side Shielding in Air . 14 3.3.1 Test Conditions 14 3.3.2 Measurement Procedure . 14 3.3.3 Calculations and Analysis 14 3.3.4 Reporting 14 3.4 Sensitivity to Scatter 15 3.4.1 Test Conditions 15 3.4.2 Measurement Procedure . 1

19、5 3.4.3 Calculations and Analysis 15 3.4.4 Reporting 16 NU 3-2004 Page ii Copyright 2004 by the National Electrical Manufacturers Association. 3.5 Spatial Resolution in a Scatter Medium 16 3.5.1 Test Conditions 16 3.5.2 Measurement Procedure . 16 3.5.3 Calculations and Analysis 17 3.5.4 Reporting 17

20、 3.6 Volume Sensitivity to Distributed Activity in a Scatter Medium. 17 3.6.1 Test Conditions 17 3.6.2 Measurement Procedure . 17 3.6.3 Calculations and Analysis 18 3.6.4 Reporting 18 3.7 Short-Term Sensitivity Stability. 18 3.7.1 Test Conditions 18 3.7.2 Measurement Procedure . 18 3.7.3 Calculation

21、s and Analysis 18 3.7.4 Reporting 19 3.8 Count Rate Capability in a Scatter Medium 19 3.8.1 Test Conditions 19 3.8.2 Measurement Procedure . 19 3.8.3 Calculations and Analysis 20 3.8.4 Reporting 20 3.9 Angular Resolution in a Scatter Medium 20 3.9.1 Test Conditions 20 3.9.2 Measurement Procedure . 2

22、0 3.9.3 Calculations and Analysis 21 3.9.4 Reporting 21 3.10 Energy Resolution. 21 3.10.1 Test Conditions 21 3.10.2 Test Equipment 22 3.10.3 Measurement Procedure . 22 3.10.4 Calculations and Analysis 22 3.10.5 Reporting 22 3.11 Side and Back Shielding . 22 3.11.1 Test Conditions 22 3.11.2 Measureme

23、nt Procedure . 23 3.11.3 Calculations and Analysis 23 3.11.4 Reporting 23 Section 4 QUALITY CONTROL TESTS 4.1 General . 24 4.2 Sensitivity 24 4.2.1 Test Conditions 24 4.2.2 Measurement Procedure . 25 4.2.3 Calculations and Analysis 25 4.2.4 Reporting 25 4.2.5 Recommended Test Frequency. 25 4.3 Visua

24、l and Physical Inspection . 26 4.3.1 Inspection. 26 4.3.2 Frequency 26 4.4 Power Source (for Internally-Powered Systems) 26 4.4.1 Checks . 26 4.4.2 Frequency 26 Performance Measurement Datasheet (example) . 27 Quality Control Datasheet (example) . 28 NU 3-2004 Page iii Copyright 2004 by the National

25、 Electrical Manufacturers Association. Tables Table 1-1 Common Radionuclides and Examples of their Surgical Applications 2 Table 1-2 Recommended Frequencies for Gamma Probe Tests 3 Table 1-3 Changes in Test Results Between Using 99mTC and 57CO 6 Table 2-1 Recommended Radiation Test Sources 10 Figure

26、s Figure 3-1 Sensitivity Test Configuration . 12 Figure 3-2 Water Bath Test Configuration for Sensitivity . 13 Figure 3-3 Sensitivity Test Configuration . 14 Figure 3-4 Sensitivity to Scatter Test Configuration. 15 Figure 3-5 Determination of FWHM and FWTM. 16 Figure 3-6 Count Rate Capability and Li

27、nearity . 19 Figure 3-7 Angular Resolution Test Configuration . 20 Figure 3-8 Energy Resolution Calculation 21 Figure 3-9 Side Shielding Test Configuration. 22 Figure 4-1 Sensitivity Test Configuration . 24 NU 3-2004 Page iv Copyright 2004 by the National Electrical Manufacturers Association. Forewo

28、rd User input has been considered in the development of this Standards Publication. The Standards Publication was developed by the Nuclear Section of the National Electrical Manufacturers Association, which will periodically review it for any revisions necessary to keep it up to date with advancing

29、technology. Proposed or recommended revisions should be submitted to: Vice President, Engineering Department National Electrical Manufacturers Association 1300 North 17th Street, Suite 1847 Rosslyn, Virginia 22209 USA CAUTION: Persons using this measurement standard must be in compliance with all ap

30、plicable federal and state regulations (Ref: NRC Regulatory Guide 10.8, Guide for the Preparation of Applications for Medical Programs) for the use, handling, and possession of radioactive material.NU 3-2004 Page 1 Copyright 2004 by the National Electrical Manufacturers Association. Section 1 PURPOS

31、E, SCOPE, AND RATIONALE 1.1 PURPOSE The purpose of this standards publication is to provide uniform criteria for conducting and reporting performance measurements and quality control tests of non-imaging intraoperative gamma probes. They are simple, inexpensive to perform, not time consuming and do

32、not require exotic or costly equipment. This Standard identifies parameters and test methods by which a manufacturer may specify the performance of a device and, when doing so, reference NEMA standards publication No. NU 3, Performance Measurements and Quality Control Guidelines for Non-Imaging Intr

33、aoperative Gamma Probes. These Quality Control Tests are recommended to ensure diagnostic accuracy in clinical practice. This standard does not establish minimum performance levels or minimum acceptance criteria for quality control tests. 1.2 SCOPE This standards publication establishes definitions

34、and describes quantitative measurements of performance characteristics and quality control tests for non-imaging intraoperative gamma probes. Performance measurement tests are as follows: a) Sensitivity in Air b) Sensitivity in a Scatter Medium c) Sensitivity through Side Shielding in Air d) Sensiti

35、vity to Scatter e) Spatial Resolution in a Scatter Medium f) Volume Sensitivity to Distributed Activity in a Scatter Medium g) Short Term Sensitivity Stability h) Count Rate Capability in a Scatter Medium i) Angular Resolution in a Scatter Medium j) Energy Resolution k) Side and Back Shielding Quali

36、ty Control Tests are set forth for the following: a) Sensitivity b) Visual Inspection c) Source of Power A serious and concerted effort has been made to include non-imaging intraoperative gamma probes of every design under the scope of this Standard. Included are probes that contain scintillating (C

37、sI, NaI) detectors and solid-state (CdTe, CZT) detectors. This Standard does not apply to non-imaging intraoperative probes that are designed to detect beta particles, such as from positron emitters including FDG. This Standard does apply to non-imaging intraoperative probes intended to detect photo

38、ns emitted from positron annihilation. In general, this Standard does not apply to hand-held or other small field of view (SFOV) imaging probes, although many of these performance measurements may apply to these devices when used in a targeting (i.e. non-imaging) manner. NU 3-2004 Page 2 Copyright 2

39、004 by the National Electrical Manufacturers Association. 1.3 INTRODUCTION This Standards Publication is classified as a NEMA Standard unless otherwise indicated and establishes definitions, quantitative measurement of performance characteristics, quality control tests, and reporting techniques. Int

40、raoperative gamma probes are becoming valuable tools for surgeons, for example in the identification of sentinel nodes and detection of recurrent, residual or occult tumors. Radionuclide localization techniques using non-imaging gamma probes are challenging and critically dependent on the performanc

41、e of the probe systems. (Approved as authorized engineering information.) The tests described for non-imaging intraoperative gamma probes are designed to provide quantitative, comprehensive, and relevant information about the performance of gamma probes used in medicine. The tests are also designed

42、to be as simple to perform as possible, though the need for accurate positioning devices and a water bath cannot be avoided. Though 99mTc is the most commonly used isotope in Nuclear Medicine, performance should also be reported for other isotopes with important applications (such as 111In). The tes

43、ts are proposed with due regard and acknowledgement to previously published work on the evaluation of gamma probes 1 7. (Approved as authorized engineering information.) 1.3.1 Applications Table 1-1 contains a list of commonly used radioisotopes and their basic physical characteristics along with a

44、list of current surgical applications. Table 1-1 COMMON RADIONUCLIDES AND EXAMPLES OF THEIR SURGICAL APPLICATIONS Radionuclide Photon energy Half-life Applications 99mTc 140 keV 6 hours COLLOIDS Sentinel node biopsy MONOCLONAL ANTIBODIES colon cancer SOMATOSTATIN ANALOGS neuroendocrine tumors SESTAM

45、IBI parathyroid adenoma or hyperplasia 111In 172 keV 247 keV 2.8 days MONOCLONAL ANTIBODIES colon/ovarian cancer SOMATOSTATIN ANALOGS neuroendocrine tumors 123I 159 keV 13 hours THYROID 131I 364 keV 8 days THYROID 57Co 122 keV 270 days CALIBRATION SOURCE 18F511 keV 110 min Fluorodeoxyglucose (FDG) N

46、eoplastic disease NU 3-2004 Page 3 Copyright 2004 by the National Electrical Manufacturers Association. 1.3.2 Basic Probe Design Intraoperative gamma probe systems are essentially composed of two functional units: 1) The hand-held probe and connecting cable, and 2) the analyzer, usually referred to

47、as the control and display unit. The detector is the component within the probe that interacts with gamma photons converting the radiation energy into signal. Detectors are made of either scintillation crystals or semiconductors. These two types of materials show differences in physical properties a

48、s well as pattern of interactions with gamma photons. Detectors collection of gamma radiation information is rather nonspecific. In other words, not only are the emissions from the radiolabeled surgical target counted, but the detector also counts the background and the scattered radiation. However,

49、 photons lose some energy when scattered, and the system can therefore reject some of the scattered photons that fall below the systems lower energy window. Photons of different energies are received, distinguished, and accepted or rejected in the analyzer unit, which additionally displays information (visually and/or aurally) to the user about the detected count rate or the accumulated counts over time. 1.4 RATI