The Importance of Training, Accreditation, and Guidelines for the Practice of Theranostics: The Australian Perspective

The Theranostic Specialist

In the AANMS position statement, a theranostic specialist is defined as a qualified nuclear medicine specialist trained in the practice of theranostics by the Committee for Joint College Training in Nuclear Medicine, which oversees nuclear medicine training in Australia, with representation from the Royal Australasian College of Physicians and the Royal Australian and New Zealand College of Radiologists. To obtain accreditation in theranostics, a qualified nuclear medicine specialist in Australia needs to meet specified accreditation and training requirements as outlined in this paper. PET and SPECT interpretation is fundamental to determining suitability for treatment, dosimetry, and response assessment for theranostic practice, and nuclear medicine provides this expertise. In Australia, nuclear medicine training includes a wide range of adult and pediatric imaging with radiopharmaceuticals; radionuclide therapy, including thyroid cancer; and radiation protection principles and legislative requirements for administering radiopharmaceuticals. The requirement for subaccreditation in theranostics within our specialty group recognizes the importance of advanced training and experience in this emerging area and the lead role of nuclear medicine in this field.

The Patient

Clinical consultation is an essential step in the proper evaluation of a patient’s suitability for radionuclide therapy, including a full clinical assessment of the patient’s medical condition and evaluation of the appropriate molecular imaging studies for the theranostic agent to be given. Careful imaging assessment underpins the decision-making process regarding the appropriateness of radionuclide therapy for each patient. This imaging must also be performed in an appropriate time frame relevant to the condition being treated in order to minimize disease progression or transformation, which may impact treatment efficacy. Again, this imaging should be performed in a multidisciplinary setting that enables accurate and shared discussion of all imaging results and clinical aspects of patient care. If treatment is recommended, the patient must be told the practical aspects and logistics of treatment, including any potential side effects and complications, management of the side effects, and long-term complications. Any radiation protection issues relevant to the patient and family members must also be communicated. Once fully informed, the patient can decide whether to proceed with treatment, and written informed consent must be obtained.

After treatment, there should be a follow-up assessment with the treating theranostic specialist according to local institutional practice, with assessment of toxicities, imaging results, and pathology results, as needed, to determine whether the patient remains suitable for further cycles of radionuclide therapy and, if so, whether any dose modifications are required. There should be ongoing multidisciplinary involvement, with shared care between the referring oncology specialist and the theranostic specialists throughout treatment, to ensure optimal holistic disease management. This aspect is particularly important in patients with more aggressive disease and pain control requirements. Shared care can involve alternating visits between the oncology and theranostic specialists (such as at 3-wk intervals). A multidisciplinary team, also known as a tumor board, may also be of value, not only at treatment onset but at seminal stages of treatment (particularly at premature cessation and when any complications arise) and to consider or coordinate other therapies, if appropriate.

Radiopharmaceutical Production

Depending on the relevant local regulations, radiopharmaceuticals may be produced by a central radiopharmacy or a local hospital-based radiopharmaceutical laboratory. The AANMS guidelines cover the specific requirements, and in alignment with our local regulatory requirements in Australia, the radiopharmaceutical can be manufactured in a departmental radiopharmacy by a trained radiopharmaceutical scientist using appropriate standard operating procedures (SOP) under good laboratory practices adopted for continued process control and high-quality standards. When applicable, radiopharmaceuticals should be prepared according to regulatory and monograph guidelines. The entire manufacturing process should be documented on a batch record or worksheet, and staff training and compliance with this procedure should be recorded. Deviations from this procedure should be documented according to site protocols. A risk-based approach to process validation should be completed before radiopharmaceuticals are prepared for human use.

Equipment used in the manufacturing and quality control testing of radiopharmaceuticals should be certified at installation and then checked routinely to ensure reliability in operation. Ongoing maintenance-and-use logs for critical equipment are also recommended. Radiopharmaceutical production in commercial radiopharmacies is performed under good-manufacturing-practice guidelines.

The final review of product quality remains the responsibility of the administering theranostic specialist.

Medical Radiation and Dosimetry

Good radiation safety practices both within the department and in the general population must be maintained according to local regulations. The development of SOPs would commonly involve a medical physicist and radiation safety officers. For outpatient treatments, the medical physicist’s advice is used to decide when patients can be released from the treating facility to their home, another residence, or back to the hospital ward. Once released, patients need to be aware of the radiation protection guidelines to be followed and for what period these apply. This advice can be given by a theranostic medical specialist, a trained medical physicist, or a nuclear medicine technologist. Any departure from normal procedures, such as a spill or an extravasated injection, will require an objective assessment of the likely implications and expert knowledge of the procedures that should be undertaken to mitigate the effect on patients. The medical physicist also plays a critical role in assisting with dosimetry and individual dose planning, as required.

Sites should have specific guidelines for each radiotherapeutic administration, with site-specific medical, nursing, and technologist protocols, as each group will often have important roles in supervising the patient before, during, and after treatment and may coordinate care arrangements. Nursing staff will also administer any required premedications for the specific radionuclide therapy and any necessary preparatory infusions (e.g., amino acids).

All departments should have SOP guidelines for delivery of therapeutic radiopharmaceuticals, to ensure absolute safety of the staff, patients, and general public.

All SOPs developed should be endorsed by both the medical physicist involved in the delivery of care at that site and the theranostic medical specialists directly responsible for care at the treatment facility. In Australia, a qualified nuclear medicine medical physics specialist accredited with the Australasian College of Physical Scientists and Engineers in Medicine must oversee this endorsement, either actively or through the use of an SOP.

General Accreditation

Completion of the minimum additional training requirements or legacy provisions for specialists in nuclear medicine will qualify the applicant for general accreditation, allowing participation in providing theranostic services. These requirements are experience with more than 50 therapies by initial consultations or administrations within the last 3 y, participation in multidisciplinary discussion of more than 50 cases, and ongoing participation in relevant continuous professional development activities (e.g., conferences or courses).

Advanced Accreditation

Practitioners who have extensive experience may apply for advanced accreditation. Advanced accredited specialists will be allowed to provide training and are a requirement for site accreditation. Advanced accredited specialists must have clinical experience that encompasses more than 120 therapy initial consultations or administrations within the last 3 y, participation in multidisciplinary discussion of more than 100 cases, ongoing participation in relevant continuous professional development activities (e.g., conferences or courses), and participation in recognized research in the field.

The training site requirements are also outlined, but the minimum level includes the presence of an accredited theranostic specialist onsite during delivery of the therapy, and other necessary staff. There should be an updated protocol manual that describes general provisions for administration of radionuclide therapies and for each specific therapy offered, including the roles of medical, radiopharmaceutical scientist, physicist, nursing, and administrative staff and the protocols for radiopharmaceutical dispensing, labeling, and disposal (as required). Regular multidisciplinary team meetings that encompass all theranostic applications used at the site are also important.