Production and regulatory issues for theranostics.

Theranostics has become a major area of innovation and progress in cancer care over the last decade. In view of the introduction of approved therapeutics in neuroendocrine tumours and prostate cancer in the last 10 years, the ability to provide access to these treatments has emerged as a key factor in ensuring global benefits from this cancer therapy approach. In this Series paper we explore the issues that affect access to and availability of theranostic radiopharmaceuticals, including supply and regulatory issues that might affect the availability of theranostic treatments for patients with cancer.

Recurrent medical imaging exposures for the care of patients: one way forward.

Medical imaging is both valuable and essential in the care of patients. Much of this imaging depends on ionizing radiation with attendant responsibilities for judicious use when performing an examination. This responsibility applies in settings of both individual as well as multiple (recurrent) imaging with associated repeated radiation exposures.

Guardians of precision: advancing radiation protection, safety, and quality systems in nuclear medicine.

Background: In the rapidly evolving field of nuclear medicine, the paramount importance of radiation protection, safety, and quality systems cannot be overstated. This document provides a comprehensive analysis of the intricate regulatory frameworks and guidelines, meticulously crafted and updated by national and international regulatory bodies to ensure the utmost safety and efficiency in the practice of nuclear medicine.

Methods: We explore the dynamic nature of these regulations, emphasizing their adaptability in accommodating technological advancements and the integration of nuclear medicine with other medical and scientific disciplines.

Safety in radiation oncology (SAFRON): Learning about incident causes and safety barriers in external beam radiotherapy.

Purpose: Safety in Radiation Oncology (SAFRON) is a reporting and learning system on radiotherapy and radionuclide therapy incidents and near misses. The primary aim of this paper is to examine whether any discernible patterns exist in the causes of reported incidents and safety barriers within the SAFRON system concerning external beam radiotherapy.

Methods And Materials: This study focuses on external beam radiotherapy incidents, reviewing 1685 reports since the inception of SAFRON until December 2021.

Communication of radiation risk from imaging studies: an IAEA-coordinated international survey.

The purpose of this IAEA-coordinated international study was to understand aspects related to the communication of radiation risk from imaging studies, such as how often imaging department personnel and referring physicians are asked about radiation risks in diagnostic imaging, who asks about these risks, how often professionals are able to provide satisfactory answers using qualitative metrics and how often quantitative risk estimates are needed. A web-based questionnaire with ten questions was completed by 386 healthcare professionals from 63 countries from all four continents, including clinicians/referring physicians (42.5%), radiologists or nuclear medicine physicians (26.

Strengthening radiation protection education and training of health professionals: conclusions from an IAEA meeting.

In March 2021 the International Atomic Energy Agency (IAEA) organised an online Technical Meeting on Developing Effective Methods for Radiation Protection Education and Training of Health Professionals with attendance of 230 participants representing 66 Member States and 24 international organizations, professional bodies and safety alliances. By means of a pre-meeting survey, presentations by experts, topical panel discussions and post-meeting feedback to the meeting summary, the meeting identified strengths, common weaknesses and possible solutions and actions for improving radiation protection education and training of health professionals. Available guidelines and resources for radiation protection training were also reviewed.

Radiation protection perspective to recurrent medical imaging: what is known and what more is needed?

This review summarises the current knowledge about recurrent radiological imaging and associated cumulative doses to patients. The recent conservative estimates are for around 0.9 million patients globally who cumulate radiation doses above 100 mSv, where evidence exists for cancer risk elevation.

How often does it happen? A review of unintended, unnecessary and unavoidable high-dose radiation exposures.

High-dose radiation exposures of humans occur every year around the world, and may lead to harmful tissue reactions. This review aims to look at the available information sources that can help answering the question of how often these events occur yearly on a global scale. In the absence of comprehensive databases of global occurrence, publications on radiation accidents in all uses of radiation and on rates of high-dose events in different medical uses of radiation have been reviewed.

Medical imaging and nuclear medicine: a Lancet Oncology Commission.

The diagnosis and treatment of patients with cancer requires access to imaging to ensure accurate management decisions and optimal outcomes. Our global assessment of imaging and nuclear medicine resources identified substantial shortages in equipment and workforce, particularly in low-income and middle-income countries (LMICs). A microsimulation model of 11 cancers showed that the scale-up of imaging would avert 3·2% (2·46 million) of all 76·0 million deaths caused by the modelled cancers worldwide between 2020 and 2030, saving 54·92 million life-years.

Variations in CT Utilization, Protocols, and Radiation Doses in COVID-19 Pneumonia: Results from 28 Countries in the IAEA Study.

Background There is lack of guidance on specific CT protocols for imaging patients with coronavirus disease 2019 (COVID-19) pneumonia. Purpose To assess international variations in CT utilization, protocols, and radiation doses in patients with COVID-19 pneumonia. Materials and Methods In this retrospective data collection study, the International Atomic Energy Agency coordinated a survey between May and July 2020 regarding CT utilization, protocols, and radiation doses from 62 health care sites in 34 countries across five continents for CT examinations performed in patients with COVID-19 pneumonia.

Chest CT practice and protocols for COVID-19 from radiation dose management perspective.

The global pandemic of coronavirus disease 2019 (COVID-19) has upended the world with over 6.6 million infections and over 391,000 deaths worldwide. Reverse-transcription polymerase chain reaction (RT-PCR) assay is the preferred method of diagnosis of COVID-19 infection.

Clinical imaging guidelines part 4: challenges in identifying, engaging and collaborating with stakeholders.

The effective development and use of clinical imaging guidelines requires an understanding of who the stakeholders are, what their interests in the process are, and what roles they should play. If the appropriate stakeholders are not engaged in the right roles, it is unlikely that clinical imaging guidelines will be successfully developed, relied on, and actually used. Some stakeholders are obvious: for the development of clinical imaging guidelines, both imagers and those who request examinations, such as general practitioners, internists, and medical specialists, must be involved.

Monitoring of clinical imaging guidelines part 3: norms, standards, and regulations.

It is known that the use of imaging in clinical situations is not always optimal, leading to suboptimal health care and potential radiation risk. There may be overuse of imaging, underuse, or use of the wrong modality. The use of clinical imaging guidelines is likely to improve the use of imaging, but roadblocks exist.

Clinical imaging guidelines part 2: Risks, benefits, barriers, and solutions.

A recent international meeting was convened by two United Nations bodies to focus on international collaboration on clinical appropriateness/referral guidelines for use in medical imaging. This paper, the second of 4 from this technical meeting, addresses barriers to the successful development/deployment of clinical imaging guidelines and means of overcoming them. It reflects the discussions of the attendees, and the issues identified are treated under 7 headings: ■ Practical Strategy for Development and Deployment of Guidelines; ■ Governance Arrangements and Concerns with Deployment of Guidelines; ■ Finance, Sustainability, Reimbursement, and Related Issues; ■ Identifying Benefits and Radiation Risks from Radiological Examinations; ■ Information Given to Patients and the Public, and Consent Issues; ■ Special Concerns Related to Pregnancy; and ■ The Research Agenda.

Clinical imaging guidelines part 1: a proposal for uniform methodology.

Inappropriate imaging can lead to unnecessary medical radiologic exposures and cost and may not answer the clinical question. Imaging referral guidelines inform the justification of radiologic procedures and facilitate the choice of the best test first, but their acceptance by referrers, use, and value may be limited by shortcomings in the methodology of development. Focusing on common, essential elements of methodology will help guideline developers.

Addressing patient safety through the use of 'criteria of acceptability' for medical radiation equipment.

Patient safety should be considered in the use of ionising radiation equipment in medicine. The International Atomic Energy Agency (IAEA) establishes standards of safety and provides for the application of these standards, also in the area of medical use of radiation. Equipment acceptability, as it relates to radiation in medicine, is the need to satisfy the requirements or standards prior to the use of the device in patient imaging or treatment.

Safety in radiation oncology: the role of international initiatives by the International Atomic Energy Agency.

The International Atomic Energy Agency (IAEA) has a wide range of initiatives that address the issue of safety. Quality assurance initiatives and comprehensive audits of radiotherapy services, such as the Quality Assurance Team for Radiation Oncology, are available through the IAEA. Furthermore, the experience of the IAEA in thermoluminescence dosimetric audits has been transferred to the national level in various countries and has contributed to improvements in the quality and safety of radiotherapy.

International action plan on the radiation protection of patients.

Realising that the major part of radiation protection efforts had been directed for over half a century at radiation protection of workers, and that there are major issues in relation to medical exposure, which contributes to over 95 % of the dose to the global population from man-made sources, with increasing individual patient doses in diagnostic examinations, unnecessary or inappropriate examinations and continued accidents in radiotherapy, the International Atomic Energy Agency established an International Action Plan (IAP) in 2002 in cooperation with international organisations and professional bodies. The achievements of the IAP, which include harmonised training material, guidance documents, a number of publications, a website on radiation protection of patients (http://rpop.iaea.

Radiation Oncology Safety Information System (ROSIS)--profiles of participants and the first 1074 incident reports.

Background And Purpose: The Radiation Oncology Safety Information System (ROSIS) was established in 2001. The aim of ROSIS is to collate and share information on incidents and near-incidents in radiotherapy, and to learn from these incidents in the context of departmental infrastructure and procedures.

Materials And Methods: A voluntary web-based cross-organisational and international reporting and learning system was developed (cf.

Current issues and actions in radiation protection of patients.

Medical application of ionizing radiation is a massive and increasing activity globally. While the use of ionizing radiation in medicine brings tremendous benefits to the global population, the associated risks due to stochastic and deterministic effects make it necessary to protect patients from potential harm. Current issues in radiation protection of patients include not only the rapidly increasing collective dose to the global population from medical exposure, but also that a substantial percentage of diagnostic imaging examinations are unnecessary, and the cumulative dose to individuals from medical exposure is growing.

The importance and unique aspects of radiation protection in medicine.

Radiation protection in medicine has unique aspects and is an essential element of medical practice. Medical uses of radiation occur throughout the world, from large cities to rural clinics. It has been estimated that the number of medical procedures using radiation grew from about 1.

A phase II trial for the optimisation of treatment position in the radiation therapy of prostate cancer.

Background: Patient immobilisation and position are important contributors to the reproducibility and accuracy of radiation therapy. In addition the choice of position can alter the external contour of the treated area and has the potential to alter the spatial relationship between internal organs. The published literature demonstrates variation in the use of the prone and supine position for prostate cancer radiation therapy.