The practice of nuclear medicine involves various variables, which is influenced by the equipment, the radiopharmaceuticals, patient preparation, and etc. Standards, regulations, and guidelines have been established to ensure the best-possible practice could be implemented in various centers. In this post, these regulations are summarized.
EANM guidelines and EARL accreditation
The European Association of Nuclear Medicine (EANM) is one of the two major associations in the field of nuclear medicine. ENAM maintains one of the most systematic set of guidelines in nuclear medicine. The quality is rather high, and covers many up-to-date topics.
One of the most relevant guidelines are FDG PET/CT: EANM procedure guidelines for tumour imaging: version 2.0. These guidelines provide detailed overview on how to perform FDG PET/CT imaging in a reproducible manner. It covers a vast variety of things to notice, all the way from eligible criteria to image interpretation, plus various information such as quality control and dosimetry.
Another relevant guidelines is Consensus nomenclature rules for radiopharmaceutical chemistry. This is one of the few papers published on a journal other than EJNMMI. EANM also has a practical guide on the nomenclature of radiotracers. Personally, I always follow the EANM nomenclature whenever possible.
The Acceptance testing for nuclear medicine instrumentation is recommended before accepting a new equipment from the manufacturer. It is like a checklist.
The EANM Research GmbH (EARL) was an initiative launched by EANM, to promote multi-center clinical research. An accreditation program was initiated by EARL, which includes a set of quality assurance standards to make sure that PET/CT scanners in different centers may yield uniform and comparative results. Resources on EARL acreditaion can be found on their webpage.
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) is one of the most influential academic association in the field of nuclear medicine. On the website, they provide information on clinical evidence and quality.
In their collection of guidelines, SNM cited FDG PET/CT: EANM procedure guidelines for tumour imaging: version 2.0. However, they specified that the guidelines are application except that “the SUV max is used in the United States as the quantitative measurement”. The SNM Practice Guideline for Sodium 18F-Fluoride PET/CT Bone Scans 1.0, on the other hand, is also adopted by EANM. Various other guidelines related to clinical practice have also been developed and endorsed by SNMMI.
A series of publications on dosimetry, including reports, pamphlets, and monographs, have been released by the Committee on Medical Internal Radiation Dose (MIRD). MIRD also provides softwares for dosimetry calculation.
Protocols for clinical trials
The Quantitative Imaging Biomarkers Alliance (QIBA) initiative is sponsored by Radiological Society of North America (RNSA) to promote the development of biomarkers and quantification protocols in clinical trials. Profiles have been proposed by QIBA, including several related to PET/CT and SPECT. For example, a special report introducing the Profile FDG-PET/CT as an Imaging Biomarker Measuring Response to Cancer Therapy was published on Radiology.
Uniform Protocols for Imaging in Clinical Trials (UPICT) is actually a template for protocol development in clinical trials involving imaging. It was developed by the Imaging Working Group under the Clinical and Translational Science Awards (CTSA) Program of NIH. The representative output of UPICT is one on Oncology FDG-PET/CT, with a summary entitled Summary of the UPICT Protocol for 18F-FDG PET/CT Imaging in Oncology Clinical Trials published on JNM. The development of UPICT is a joint work with QIBA.
The National Cancer Institute (NCI) released a consensus in 2006, Consensus Recommendations for the Use of 18F-FDG PET as an Indicator of Therapeutic Response in Patients in National Cancer Institute Trials, which is also related to clinical trials.
The image biomarker standardisation initiative (IBSI) is an independent international collaboration of researchers aiming at providing a unified framework for radiomics. There are two chapters, and the first one (IBSI 1) is now completed.
They have published an article on Radiology. Several documentations from IBSI 1 and IBSI 2 are available from the website.
IBSI has already become the actual standard in radiomics research.
RECIST and PERCIST
Response Evaluation Criteria in Solid Tumours (RECIST) is a set of criteria to measure the tumor’s response to treatment. It was a joint effort among several institutes and organizations. The impact of RECIST is huge in the oncological research and clinical practice. PET/CT was cited as an evaluation method in the latest version of RECIST 1.1.
There are various types of variants of RECIST, which are specifically optimized towards specific applications. Among them, PET Response Criteria in Solid Tumors (PERCIST) has been the most influential recommendations for PET evaluation of tumor response.
NEMA, IEC, and AAPM standards
The performance measurement of PET and SPECT scanners are very important in the development of new equipment, and the maintenance and quality control could also use it as a reference.
There are two major forms of standards related to performance evaluation of PET scanners, as for many other electrical devices. The first standard is NEMA NU2 by the National Electrical Manufacturer Association (NEMA). The other is IEC 61672-1 by International Electrotechnical Commission (IEC). Overall, the NEMA standard are more widely used than the IEC standard. The current NEMA standard was published in 2018, and the new 2023 version is being prepared. The current IEC standard was publihsed in 2022.
The American Association of Physics in Medicine (AAPM) is an association for medical physicists. Together with American College of Radiology (ACR), they publish a series of guidelines on the quality control of nuclear medicine equipment, including PET. However, unlike the NEMA and IEC standards, the ACR-AAPM technical standards are not intended for supervision applications.
The International Atomic Energy Agency (IAEA) is an international organization affiliated to the United Nations. IAEA publishes many reports on various aspects of nuclear science and engineering, including nuclear medicine. Most such reports are published in the Human Health Series and the Safety Reports Series.
The scope of Appropriate Use of FDG-PET for the Management of Cancer Patients is similar to the EANM FDG PET/CT in oncology guidelines. Standard Operating Procedures for PET/CT: A Practical Approach for Use in Adult Oncology is also quite similar.
Nuclear Medicine Resources Manual 2020 Edition on the other hand, provides some context about the operational aspect of a nuclear medicine facility. While QUANUM 3.0: An Updated Tool for Nuclear Medicine Audits is a protocol for auditing, and it also shows how to manage a nuclear medicine facility.
Several atlases including Atlas of Non-FDG PET–CT in Diagnostic Oncology, Clinical PET/CT Atlas: A Casebook of Imaging in Oncology, and PET/CT Atlas on Quality Control and Image Artefacts are all very interesting.
Various other reports covers topics such as radiation protection (Radiation Protection in Newer Medical Imaging Techniques: PET/CT), nuclide production (Cyclotron Produced Radionuclides: Emerging Positron Emitters for Medical Applications: 64Cu and 124I), radiopharmaceuticals (Production and Quality Control of Fluorine-18 Labelled Radiopharmaceuticals ), and so on.
The International Commission on Radiological Protection (ICRP) is an organization devoted to the research on radiation protection. It is made of four committees and several task groups.
ICRP publishes many reports on radiation protection, and many of them are highly emphasized in the study of medical physics, including radiotherapy and radiology. ICRP Publication 103, The 2007 Recommendations of the International Commission on Radiological Protection is about the a system of radiological protection, which substituted the former ICRP Publication 60. It introduces the basic ideas in radiation protection. ICRP Publication 105 is Radiological Protection in Medicine, which deals with the health hazard of ionizing radiations in clinical practice. ICRP Publication 106 Radiation Dose to Patients from Radiopharmaceuticals - Addendum 3 to ICRP Publication 53 introduces methods to calculate the dose of radiopharmaceuticals, including models and recommended parameters. ICRP Publication 135 Diagnostic Reference Levels in Medical Imaging sets a “diagnostic reference level (DRL)” for various medical imaging modalities.
Pharmacopeia and GMP
Pharmacopoeia are official documents for pharmaceuticals. The European Pharmacopoeia (Ph. Eur.) is a highly influential pharmacopoeia, and the latest effective version in Edition 10, and the 11th edition in on the way. The pharmacopoeia is comprised of a large number of monographs and general texts, and a bunch of them are related to radiopharmaceuticals. Chapter 10 of Ph. Eur. contains monographs for different approved radiopharmaceuticals.
The United States Pharmacopoeia (USP) is effective in the United States. Monograph <821> Radioactivity, <823> Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses, and <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging are some related monographs in the General Chapter.
Good manufacturing practices (GMPs) are maintained by producers of pharmaceuticals, and there are specific regulations regarding radiopharmaceuticals. Working with IAEA, the WHO team of health product and policy standards has published a report, providing the GMP for radiopharmaceutical products.
As an extension of the European Union GMP (EudraLex Volume 4), a team of experts from the Radiopharmacy Committee of EANM proposed the Guideline on current good radiopharmacy practice (c)GRPP) for the small-scale preparation of radiopharmaceuticals.
Other related information
- The Nuclear Regulatory Commission (NRC) published a Guide for Diagnostic Nuclear Medicine.
- The American College of Radiology (ACR) issued accreditation documents about nuclear medicine and PET.
- The American Society of Radiologic Technologist (ASRT) issued The ASRT Practice Standards for Medical Imaging and Radiation Therapy, and the related contents on nuclear medicine is excerpted as a separate document.
- A review article was published by scientists from different institutions on JNM, entitled Reporting Guidance for Oncologic 18F-FDG PET/CT Imaging.