Joint EANM, SNMMI, and IAEA Enabling Guide: How to Set up a Theranostics Center

Abstract

The theranostics concept using the same target for both imaging and therapy dates back to the middle of the last century, when radioactive iodine was first used to treat thyroid diseases.Since then, radioiodine has become broadly established clinically for diagnostic imaging and therapy of benign and malignant thyroid disease, worldwide. However, only since the approval of SSTR2-targeting theranostics following the NETTER-1 trial in neuroendocrine tumours, and the positive outcome of the VISION trial has theranostics gained substantial attention beyond nuclear medicine. The roll-out of radioligand therapy for treating a highincidence tumour such as prostate cancer requires the expansion of existing, and the establishment of new theranostics centres. Despite wide global variation in the regulatory, financial and medical landscapes, this guide attempts to provide valuable information to enable interested stakeholders to safely initiate and operate theranostic centres. This enabling guide does not intend to answer all possible questions, but rather to serve as an overarching framework for multiple, more detailed future initiatives. It recognizes that there are regional differences in the specifics of regulation of radiation safety, but common elements of best practice valid globally.

Validation of the SSTR-RADS 1.0 for the structured interpretation of SSTR-PET/CT and treatment planning in neuroendocrine tumor (NET) patients

“…Since the theranostic approach for NET has developed into a standardized diagnostic and therapeutic procedure in recent years, accurate assessment of the overall scan score is of utmost importance for selecting eligible patients for PRRT [ 6 , 12 , 18 – 20 ]. Our analysis showed that less experienced readers considered PRRT overall more often ( n = 228) than experienced readers ( n = 188), which underlines the findings from previously published data.…”

“…However, further clinical studies are required to evaluate the clinical outcome of patient selection for PRRT based on SSTR-RADS 1.0 score. An appropriate scan score is of utmost importance for selecting eligible patients for PRRT [ 12 , 20 ] and the nuclear medicine physicians’ general statement “functional imaging fulfills requirements for PRRT and qualifies patient as potential candidate for PRRT.” Moreover, in all cases PRRT is considered, double reading should be implemented by a senior physician. However, a definite treatment decision for PRRT in a theranostic center requires clinical case discussion in a multidisciplinary team (MDT) [ 20 ], and MDTs are considered a quality performance indicator [ 22 ].…”

“…An appropriate scan score is of utmost importance for selecting eligible patients for PRRT [ 12 , 20 ] and the nuclear medicine physicians’ general statement “functional imaging fulfills requirements for PRRT and qualifies patient as potential candidate for PRRT.” Moreover, in all cases PRRT is considered, double reading should be implemented by a senior physician. However, a definite treatment decision for PRRT in a theranostic center requires clinical case discussion in a multidisciplinary team (MDT) [ 20 ], and MDTs are considered a quality performance indicator [ 22 ]. The MDT board discussion should include multiple parameters such as patient history, tumor load, tumor dynamic, primary tumor location, tumor grading, and alternative systemic and local treatment options and thus provide a profound basis for a MDT decision.…”

Establishing a robust radioligand therapy program: A practical approach for North American centers

“…MDTs are important for providing robust and well‐coordinated care, as they allow team members from various specialties to discuss treatment strategies and patient management 19,22 . RLT guidelines affirm the importance of MDTs in the successful operation of RLT programs 10 …”

“…2.1.4 | Radiation safety program and radiation safety officer RAM licensing requires an appropriate radiation safety program for the handling and disposal of radioactive materials. 7,10,19 The RSO is a key participant in this program 18 and is also responsible for ensuring that institutions meet any additional region-specific regulations. Although RSOs are ultimately responsible for the safe use of radioactive materials at an institution, the RSO may form a radiation safety team and designate other individuals to perform specific tasks.…”