Introduction

The field of theranostics represents a synergistic and dynamic convergence of specific targeted imaging and therapy, offering a paradigm shift in the management of various diseases, particularly cancers [1,2,3,4,5,6,7,8,9,10]. As this innovative approach gains momentum, the importance of a multidisciplinary approach cannot be overstated. A successful nuclear theranostics program is built upon a comprehensive foundation that encompasses advanced equipment and regulatory compliance and the collective expertise of a diverse team [11,12,13]. The need for the multidisciplinary team to embrace the humanistic and technical components of modern healthcare would bring the expertise of nuclear medicine physicians, other theranostics qualified cancer specialists, and professionals well-versed in evolving regulatory standards, together to form a synergistic force to navigate the intricacies of theranostics to deliver optimal patient care.

Nuclear medicine physicians and qualified specialists serve as the cornerstone of this theranostics multidisciplinary team. Their expert knowledge of unsealed radiation sources of radiopharmaceuticals used in theranostics, oversight and interpretation of molecular imaging studies, assessment and management of patients for theranostics treatment, and radiation safety requirements lays the groundwork for accurate disease identification, staging, and appropriate treatment decisions and implementation [11,12,13,14,15]. Working closely with nuclear medicine technologists, nurses, radiopharmaceutical scientists/radiochemists, and medical physicists ensures that the diagnostic and therapeutic phases of theranostics are executed precisely, allowing patient selection and treatment to be delivered in a timely and professional manner. Other specialists, including medical oncologists, radiation oncologists, endocrinologists, surgeons, palliative care, and pain specialists, are equally integral to this team, and the need to foster collaborative discussions among these specialists will refine treatment strategies, each contributing a unique perspective informed by their respective domains [12,13,14,15].

Navigating the evolving landscape of regulatory requirements is a shared responsibility that extends across all disciplines [12, 13, 16,17,18]. Regulatory bodies continuously adapt as theranostics evolve in order to ensure patient safety and quality care. The multidisciplinary team must stay abreast of these changes, integrating new guidelines seamlessly into their practice. This dynamic interplay between medical expertise and regulatory compliance is crucial, underscoring the need for ongoing education and cross-disciplinary communication.

In the practice of theranostics, where diagnostics and therapy harmonise, multidisciplinary team education, advanced equipment, and evolving regulatory adherence coalesce. The collective expertise of nuclear medicine physicians, radiation oncologists, and other cancer specialists, informed by a keen understanding of regulatory dynamics, forms the bedrock of safe and effective theranostics practice. This results in a patient-centric approach that capitalises on the transformative potential of theranostics, leading to improved outcomes and redefining the trajectory of modern nuclear medicine [11,12,13].

Standardised education and training programs are pivotal in ensuring a competent workforce capable of delivering high-quality theranostics nuclear medicine services. It is well known that there is significant regional diversity in nuclear medicine practice worldwide, including incorporation of modern theranostics practice [13]. Efforts have been made by major professional organisations such as the International Atomic Energy Agency (IAEA), the European Association of Nuclear Medicine (EANM), the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the Australasian Association of Nuclear Medicine Specialists/ Australian and New Zealand Society of Nuclear Medicine (AANMS/ANZSNM), the International Centres for Precision Oncology (ICPO), and other professional regional groups in nuclear medicine to standardise the basic minimum requirements for training in theranostics [12, 13, 17,18,19] (https://www.uems.eu/__data/assets/pdf_file/0009/166977/UEMS-2023.38-European-Training-Requirements-for-the-Specialty-of-Nuclear-Medicine.pdf). Standardised education fosters uniformity and consistency in knowledge acquisition and skill development by defining core competencies, curricula, and training requirements. Establishing minimum facility requirements is essential to maintain consistency and uniformity in theranostics nuclear medicine practice. Regulatory bodies are crucial in overseeing and ensuring adherence to standardised practices within the theranostics nuclear medicine field, and standardisation through regulatory oversight establishes a framework for accountability, quality control, and continuous improvement, safeguarding patients and practitioners.

In the era of precision medicine, theranostics holds immense potential in improving patient care and treatment outcomes. However, to maximise its benefits, it is crucial to establish standardised practices across the field. An IAEA meeting was held in May 2023 with representation of experts in theranostics practice and education, aiming to establish global guidelines in theranostics training. This consensus white paper addresses the guiding principles on standardising education and training for theranostics practitioners, minimum facility requirements, and regulatory body responsibilities to streamline the theranostics nuclear medicine profession (including radiation oncology in the USA) under the scaffolding principle of social and technical health system requirements for multidisciplinary team practice. These recommendations are intended to be the minimum required for safe and effective practice of theranostics by qualified physicians, and are not intended to replace an existing comprehensive nuclear medicine training program that already addresses all of the recommendations of this white paper.

Education and training for theranostics: building competencies for the multidisciplinary theranostics team

Building educational competence for practitioners in theranostics is fundamental in ensuring safe and effective patient care [12, 13, 17,18,19] (https://www.uems.eu/__data/assets/pdf_file/0009/166977/UEMS-2023.38-European-Training-Requirements-for-the-Specialty-of-Nuclear-Medicine.pdf). The significance of robust academic preparation, encompassing nuclear medicine physicians, radiation oncologists, other clinicians, and professionals, should not be understated. This comprehensive multidisciplinary approach involves establishing basic requirements and nurturing continuous professional education, ultimately fostering a proficient and adaptable workforce capable of navigating the complexities of theranostics applications. Overall, the training requirements and subsequent professional development for theranostic practitioners should allow the following outcomes:

  • Emphasise the importance of proficiency in providing appropriate patient care, medical knowledge, interpersonal skills, practice-based learning and improvement, professionalism, and ethical behaviour;

  • Encourage continuous professional development and acquisition of new competencies in theranostics practices for nuclear medicine specialists or appropriately qualified and credentialed physicians;

  • Produce knowledgeable and competent physicians capable of adapting to advancements in the field and expanding the scope of theranostic practice.

The theranostic training curriculum proposed in this white paper aims to support Nuclear Medicine and other qualified physicians in performing radiopharmaceutical theranostic applications based on well-defined/established guiding principles (Table 1). Currently, there is variability in the quality and training pathways available worldwide for practicing radiopharmaceutical theranostics [13]. Therefore, there is a need to establish minimum basic requirements and harmonise training in this field. Standardising the training approach ensures compliance with optimal standards of theranostic care. Trainees and certified physicians are encouraged to collaborate closely with clinicians in departments where most radiopharmaceutical therapy referrals originate. This curriculum provides guidance on the role of qualified physicians, aiming to meet quality standards for training in clinical nuclear medicine imaging and radiopharmaceutical therapies. It equips physicians with the knowledge, competencies, and skills required to deliver high-quality, safe, and appropriate theranostic care. This curriculum also suggests minimum standards for training other qualified physicians for safe and effective theranostics practice. This guideline complements the Training Curriculum for Nuclear Medicine Physicians (IAEA-TECDOC-1883) published in 2019 by the IAEA [17] and the Syllabus of UEMS Educational Training Requirements for nuclear medicine physicians in Europe (https://www.uems.eu/__data/assets/pdf_file/0009/166977/UEMS-2023.38-European-Training-Requirements-for-the-Specialty-of-Nuclear-Medicine.pdf).

Table 1 Guiding principles on the curriculum objectives for theranostics education for physicians
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Nuclear medicine physician education: curriculum requirements for theranostics practice

Nuclear medicine physicians, and/or other qualified specialists, play a central role in theranostics, requiring a deep understanding of molecular imaging, radiopharmaceuticals, radiation safety, and targeted therapies. There is a need for strong theoretical foundation in nuclear medicine, encompassing principles of radiopharmacology, imaging instrumentation, and radiation protection [12, 13, 17, 20]. Advanced learning delves into oncology, pharmacokinetics, and quantitative imaging techniques. Clinical rotations expose practitioners to diverse patient populations and imaging scenarios, honing their diagnostic skills. However, the evolving landscape of theranostics necessitates continuous learning and curriculum re-engineering. Nuclear medicine physicians and qualified specialists must stay current with emerging radiopharmaceuticals, dosimetry techniques, and cancer treatment protocols. Participation in specialised workshops, conferences, and collaborative multidisciplinary meetings ensures they remain abreast of cutting-edge developments in all aspects of disease management to ensure that theranostics is incorporated into the patient treatment plan at the appropriate juncture of the patient journey. As theranostics expands beyond oncology into areas like neurology and cardiology, a broadened curriculum becomes imperative, highlighting the interdisciplinary nature of theranostic practice.

Basic training requirements and continuous professional education

Establishing basic educational requirements in Nuclear Medicine training [13, 14, 17] ensures a minimum level of competency across all practitioners in the field, including provisions for some training in therapy (e.g., thyroid cancer, hyperthyroidism, bone metastases). Certifications, licenses, and standardised examinations validate this proficiency, underpinned by a comprehensive curriculum covering theoretical and practical aspects. These prerequisites serve as a crucial foundation, instilling confidence in the practitioners’ abilities to deliver safe and effective theranostics.

Theranostics is a dynamic field characterised by rapid advancements. Continuous professional education becomes indispensable to maintaining competence. Regular refreshers on radiation safety protocols, dosimetry refinements, quality systems, and new technologies and radiopharmaceuticals are vital [21,22,23]. Interdisciplinary workshops encourage collaborative learning, fostering a shared language among diverse practitioners. Furthermore, engaging with case studies and peer-reviewed literature informs practitioners about real-world applications and challenges.

Entry requirements and pathways for theranostics practice

  1. 1.

    Qualified medical practitioners/licensed physicians

    1. A.

      Nuclear Medicine physicians who have completed appropriate training and hold a license to practice nuclear medicine

    2. B.

      Qualified physicians from other specialties (including radiation oncology, radiology, and endocrinology, although not exclusively) who have completed appropriate training and are qualified and credentialed in theranostics, according to national regulations (see section below for more details)

  2. 2.

    Physicians undergoing training in relevant specialty (e.g., nuclear medicine, radiation oncology, radiology, endocrinology)—with appropriate training in theranostics (as below)

A comprehensive theranostics training program is crucial to equip healthcare professionals with the knowledge, skills, and confidence needed to excel in this advanced field’s diagnostic and therapeutic applications. Emphasis is recommended to include the following subject matters and competencies in the existing curriculum (Table 2). Assessment methods can follow recommendations from IAEA-TECDOC-1883 [17] or standard requirements as prescribed by individual training programs.

Table 2 Recommended subject matter and competencies for theranostics training
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A comprehensive theranostics training program should combine didactic learning and practical experience to clinical cases. It should foster critical thinking, problem-solving, and valuable communication skills to ensure practitioners are well-prepared to navigate the intricacies of theranostics practice. In view of the rapid changes in theranostics practice and approvals, regular updates to a theranostics curriculum should be performed. Continuous professional development opportunities should be offered to stay current with advancements in the field and evolving regulatory standards. This multifaceted training approach will ultimately contribute to a confident, skilled, and proficient workforce capable of delivering high-quality theranostics care.

Minimum procedures required to certify competence in theranostics practice

Having a minimum requirement of number of patients procedures in theranostics is essential to ensure competency and safe clinical practice of theranostics. The key criteria for minimum training and numbers of theranostic procedures for credentialing include:

  1. 1

    Clinical Proficiency: A minimum requirement ensures that the individual has gained adequate hands-on experience to develop clinical proficiency in performing theranostic procedures. This expertise is crucial for accurate diagnosis and effective treatment.

  2. 2

    Patient Safety: Handling a sufficient number of cases helps professionals become adept at managing potential complications and ensuring patient safety. It minimises the risk of errors and improves overall patient care.

  3. 3

    Skill Development: The more patients a theranostics practitioner interacts with, the more they refine their diagnostic and therapeutic skills. This ensures that they can adapt to various clinical scenarios and provide personalised treatments.

  4. 4

    Decision-Making Abilities: Experience with a diverse patient population helps in honing the ability to make informed decisions about treatment options, dosage, and follow-up care, which is critical in theranostics.

  5. 5

    Quality Management: Minimum requirements help maintain a certain standard of care and quality management within the field of theranostics. It ensures that experts have demonstrated competence through a substantial number of cases.

  6. 6

    Professional Accountability: It holds theranostics experts accountable for their practice and encourages continuous learning and improvement. Meeting minimum requirements demonstrates a commitment to ongoing professional development.

  7. 7

    Peer Recognition: Achieving the minimum patient requirements can enhance an expert’s reputation among peers and colleagues, highlighting their dedication and expertise in theranostics.

Establishing minimum patient requirements for credentialling of theranostics experts ensures that they have the necessary competence, skill, and experience to provide high-quality patient care (Table 3). For practicing nuclear medicine physicians or qualified specialists who have performed the required number of cases during their residency/training program, and want to perform therapies or start a theranostic service, there should be a requirement of current competency in theranostics practice.

Table 3 Minimum required numbers of theranostics procedures for approved competence in theranostics practice*
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Involvement of different professional groups in theranostics

It is recognised that there is some variation of theranostics practice worldwide, and there are potential roles of other physicians as theranostics practitioners [12, 13, 20]. The treating physician should be board-certified in nuclear medicine or a qualified and credentialed physician in theranostics, according to national regulations. The administering treating physician holds the responsibility for the safe administration of therapeutic radiopharmaceuticals and should directly supervise the process. Clinical consultation plays a vital role in evaluating a patient’s suitability for radiopharmaceutical therapy, involving a comprehensive assessment of the patient’s medical condition and appropriate molecular imaging studies. Imaging assessment guides the decision-making process regarding the suitability of radiopharmaceutical therapy for each patient, considering the timing to minimise disease progression/transformation that may affect treatment efficacy.

Beyond nuclear medicine physicians, a multidisciplinary approach brings together various clinicians and professionals. Medical oncologists, radiation oncologists, surgeons, radiologists, medical physicists, and nuclear medicine technologists all contribute their expertise. A foundational understanding of nuclear medicine principles, albeit at varying depths, is essential for these clinicians to collaborate effectively. This is evident worldwide with even more variations in theranostics practice in individual countries. For instance, medical oncologists require insights into radiopharmaceutical mechanisms, potential synergies with systemic therapies, and therapeutic dose implications. Radiation oncologists benefit from grasping the intricacies of theranostic internal dosimetry, appreciating how targeted unsealed radiation sources complement external beam therapy. Surgeons should understand pre-therapeutic imaging to inform surgical planning, ensuring optimal patient outcomes.

Multidisciplinary meetings (MDM), also known as “tumour boards” in oncology settings, are essential not only at the beginning of treatment but also at various stages, including premature cessation and complications. MDMs facilitate comprehensive discussions on imaging and clinical aspects of patient care. If treatment is recommended, the patient must be provided with practical information, logistics, potential side effects, complications, and radiation safety information relevant to their management. The treating physician or another member of the treating team delivers radiation protection instructions to the patient and family members based on national regulations and approved SOPs.

Follow-up assessments with the treating physician are conducted according to local institutional practices, including toxicity evaluations, imaging, and pathology results, to determine the patient’s suitability for further cycles of radiopharmaceutical therapy, considering any necessary dose modifications. Shared care may involve visits to various clinics.

With the expansion of theranostics to other fields of medicine beyond oncology in the future, similar multidisciplinary groups and meetings should be established and involve relevant specialty clinicians.

Theranostics Training Centres

Establishing a Theranostics Training Centre necessitates the presence of qualified personnel, appropriate equipment, suitable teaching facilities, and a minimum annual performance of diverse diagnostic and therapeutic (theranostics) procedures (Table 4) as well as a strong quality assurance and improvement program, and scientific research, participation in clinical trials and scientific publications. Such resources enhance patient care and ensure a safe environment while facilitating access to crucial radiopharmaceuticals. Adequate equipment providing high-resolution images that guide treatment decisions and therapeutic planning including Positron Emission Tomography (PET/CT, PET/MRI) which are essential for accurate diagnosis and staging, and Single-Photon Emission Computed Tomography (SPECT/CT) which is essential for dosimetry must be available at a training centre. In theranostics, where personalised treatment is paramount, precise diagnostic information is a cornerstone. Properly maintained equipment ensures patients receive the most accurate diagnoses, enabling tailored therapeutic interventions.

Table 4 Personnel requirements for establishing a Theranostics Training Center
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Equally crucial is having infrastructure that supports the administration of radiopharmaceutical therapies. Specialised facilities, such as dedicated infusion rooms and inpatient treatment rooms with appropriate radiation shielding, are essential for safely delivering radiopharmaceutical therapies. These facilities minimise radiation exposure to patients and healthcare workers while ensuring the therapies are effectively administered. Adequate infrastructure and protocols prevent accidental radiation exposure and contribute to safe and effective treatment. Some centres have the necessary infrastructure for radiopharmaceutical production and quality control (https://www.uems.eu/__data/assets/pdf_file/0009/166977/UEMS-2023.38-European-Training-Requirements-for-the-Specialty-of-Nuclear-Medicine.pdf.) [24,25,26]. This is particularly vital in theranostics, where the availability of specific radiopharmaceuticals is critical, and recognising that supply of radiopharmaceuticals from licensed radiopharmacies to a theranostics site is also an acceptable approach for theranostics practice. Access to radiopharmaceuticals that enable both diagnostic imaging and targeted therapy is a defining feature of theranostics. The minimum requirements for a Theranostics Training Centre is outlined in Table 5, recognising that different levels of clinical activity impact on suitability for training in clinical practice of Theranostics.

Table 5 Minimum requirements for a Theranostics Training Centre
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The minimum recommended institutional requirements in Table 5 must also be subject to local regulatory compliance requirements.

A well-equipped and staffed theranostics facility enhances the patient experience. Patients can receive diagnostic imaging and therapeutic interventions in one location, minimising the need for multiple appointments and travel. Adequate infrastructure ensures that patients receive care within a comfortable and patient-centred environment, contributing to overall satisfaction and adherence to treatment plans. Private facilities and hospitals must adhere to stringent regulatory guidelines governing the use of radioactive materials and radiation-emitting equipment. Having adequate infrastructure ensures compliance with these regulations, safeguarding patient and staff safety. Properly designed shielding, radiation monitoring systems, and radiation safety training for staff members are all critical components of maintaining a safe environment for theranostics practice.

Regulatory considerations for the implementation of theranostics training programs

Theranostics practice involves using unsealed radioactive materials and radiation-detecting equipment, making it subject to a complex framework of legislation, regulatory requirements, and approvals. This framework is designed to ensure patient safety, staff safety, and proper management of radioactive waste. Local regulations and legislative compliance will always take precedence over the suggested recommendations. Regulatory bodies at the national and international levels play a crucial role in overseeing and enforcing these requirements. Organisations like the IAEA, EANM, SNMMI, ANZSNM, UEMS contribute to developing international guidelines and standards for nuclear medicine practices, including theranostics. The following guiding principles are to assist the regulatory framework and ensure that there is safety, availability, and access for patients to theranostic procedures and to facilitate training programs (Table 6).

Table 6 Guiding principles for theranostics regulatory frameworks
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The regulatory framework for theranostics radiopharmaceutical approval is critical to ensuring patient safety, equitable access, and practical implementation in clinical practice, especially in developing countries. This framework involves various processes, including radiopharmaceutical development, clinical trials, health technology assessment (HTA), and regulatory approvals. Each country has its own set of laws and regulations governing nuclear medicine practices, which encompasses theranostics. This includes guidelines for inpatient treatment based on radiation dose, disposal of waste, and staff and public radiation exposure limits. These laws also define the legal framework for possessing, using, and disposing of radioactive materials, radiation-emitting devices, and medical equipment. Regulatory bodies, such as nuclear regulatory commissions or health ministries, enforce these laws. Facilities that intend to provide theranostics services must obtain licenses or authorisations from these regulatory bodies. These licenses outline the scope of practice, equipment specifications, and safety protocols. Regulatory requirements include radiation safety measures to protect patients from unnecessary radiation exposure.

The IAEA establishes safety standards and guidelines that member states are encouraged to adopt. These standards cover radiation protection, patient dose optimisation, and quality assurance [32,33,34]. This involves setting maximum permissible radiation doses, establishing protocols for patient positioning, and monitoring radiation levels during procedures. Developing countries may require capacity building and technology transfer to implement theranostics effectively. Collaborative efforts between regulatory authorities, international organisations, and experts from developed countries can facilitate knowledge exchange, training, and local infrastructure development.

Summary

In the era of precision medicine, theranostics is the integration of diagnostic and therapeutic approaches in nuclear medicine using unsealed radiation sources, and holds immense potential in improving patient care and treatment outcomes. This consensus white paper highlights guiding principles required for training and credentialling of theranostics physicians, and establishing Theranostics Training Centres. This will facilitate the access and availability of theranostics globally, and improve patient outcomes through a multidisciplinary theranostics team approach. By utilising the collective expertise of nuclear medicine physicians and other cancer specialists, as well as others in the multidisciplinary theranostics team, this will form the l framework required for a patient-centric approach to the practice of theranostics in the future.