Increasing access to theranostics: SNMMI applauds The Lancet Oncology Commission Report

Reston, VA (October 30, 2024, 12:00 pm ET)—SNMMI applauds The Lancet Oncology Commission for its recognition of the growth of theranostics and shedding light on the challenges and opportunities that exist to increase access to this promising field in countries around the world. The Commission’s report, released today, follows a series of articles recently published by The Lancet Oncology about the rapid expansion of theranostics.

“Theranostics is a medical innovation like none other, with a unique ability to pinpoint areas of disease in the body, quantitate and deliver personalized therapies to eradicate it at the molecular level,” said Cathy Sue Cutler, PhD, FSNMMI, president of SNMMI. “It has proven to have a meaningful impact on patients’ lives already, and nuclear medicine researchers are working diligently to unlock its full potential.”   

“Theranostics” is a two-step nuclear medicine technique that pairs two specialized drugs—a diagnostic drug and a therapeutic drug—to treat cancer and other diseases. First, the diagnostic drug is injected, seeking out and binding to disease cells, which are then made visible using a PET or SPECT scan. Once the diagnostic drug identifies the disease cells, the therapeutic drug can be administered, precisely targeting those cells to destroy the disease while sparing the surrounding healthy tissue.

Theranostics arose in the early 1940s when radioactive iodine (¹³¹I) was used to identify and to treat hyperthyroidism and later thyroid cancer. Today, theranostics is also used to treat neuroendocrine tumors (NETs) with peptide receptor radionuclide therapy, prostate cancer with PSMA therapy, liver cancer, and bone metastases. Research on other applications for theranostics is extensive, with preclinical and clinical studies in progress on diseases such as ovarian cancer, renal cell cancer, lymphoma (including a cure in a mouse model), and brain tumors.

As pointed out by The Lancet Oncology Commission, the use of theranostics—aside from ¹³¹I—remains inconsistent, with significant variability across countries. Action is needed to ensure equitable access and availability for patients in both high-income and low-to-mid-income countries. SNMMI and its members are continuing their work to advance the science and improve the accessibility and use of theranostics in the United States and across the world through multiple programs and initiatives, such as those highlighted below.

Radiopharmaceutical Therapy Centers of Excellence
SNMMI established the Radiopharmaceutical Therapy Centers of Excellence program to recognize sites that meet stringent regulatory, training, qualification, experience, and performance criteria for radiopharmaceutical therapy. As a Comprehensive, Clinical or Registered Therapy Center, institutions can assure patients, their families, referring physicians, and payors that rigorous protocols are followed, ensuring appropriate patient selection and helping ensure strong outcomes from radiopharmaceutical therapy. Currently, there are 94 approved sites: 46 Comprehensive Centers of Excellence, 24 Clinical Centers of Excellence, and 24 Registered Therapy Sites.

Radiopharmaceutical Therapy Registry
SNMMI created the Radiopharmaceutical Therapy Registry (RaPTR) to provide a structured framework for collecting clinical data and images on patients receiving radiopharmaceutical therapies. The registry aims to enhance patient safety, optimize outcomes and advance the field. It also facilitates the sharing of best practices, the development of tools, resources, and standards, and the use of registry data to advocate for appropriate reimbursement.

Research Grants for Theranostics
In 2023, SNMMI launched its Mars Shot initiative, a program created to fund research projects that have the potential to significantly enhance patient care. This summer the Mars Shot continued its work, funding two $100,000 research projects to advance radiopharmaceutical therapies for prostate cancer. The most recent Mars Shot grant supported the establishment of a centralized dosimetry process within an expanding radiopharmaceutical therapy program in a community-based healthcare system.

Guideline Development
Together with the European Association of Nuclear Medicine and the International Atomic Energy Agency, SNMMI developed guidelines for how to set up a theranostics center. The guidelines, created for use around the world, cover regulatory considerations and requirements, logistical and technical challenges, medical considerations including training, collaboration with clinical partners, treatment indications, and important lessons learned from early adopters of theranostics. The SNMMI Quality of Practice domain is also developing a procedure standard for imaging patients following ¹⁷⁷Lu therapies; release is planned for February 2025.

The Journal of Nuclear Medicine
Since its inception in 1960, The Journal of Nuclear Medicine (JNM) has published extensive research on theranostics. Starting with ¹³¹I treatment for thyroid disease to PSMA therapy for prostate cancer, leading researchers have shared their preclinical research and studies on clinical implementation with JNM. The rapid growth in radiopharmaceutical therapy research has led JNM to include a new section in the journal dedicated specifically to theranostics, and a theranostic supplement will be published in 2025.

Conferences and Education
SNMMI offers numerous opportunities for nuclear medicine professionals to learn about advances in theranostics and connect with colleagues from around the world. The society’s most recent Therapeutics Conference, which offered informative sessions, exhibits, and networking, attracted more than 300 participants including researchers, clinicians, government representatives, and suppliers. Last May, SNMMI hosted a successful workshop on Dose Optimization in Radiopharmaceutical Therapy Development, where participants discussed dose optimization strategies. SNMMI’s Annual Meeting and Mid-Winter Meeting offer sessions on theranostics and opportunities for collaboration.

Dosimetry
In 2021, the SNMMI Dosimetry Taskforce launched a community-based science challenge to respond to the need for harmonized methods for internal dosimetry for radiopharmaceutical therapies. Researchers from 18 countries analyzed data from patients treated with ¹⁷⁷Lu-DOTATATE radiopharmaceutical therapy, leading to actionable recommendations aimed at  reducing variability and standardizing dosimetry results and methods. The Task Force is currently leading the creation of an online, multi-level dosimetry curriculum for technologists, physicians, and physicists.

In addition, SNMMI’s Medical Internal Radiation Dose (MIRD) Committee has updated its “MIRD Primer” to incorporate recent advancements in radiopharmaceutical therapy. The primer is a clear, concise explanation of the MIRD schema, which has served as a worldwide standard for internal radionuclide dosimetry for more than a half century. It provides guidance on treatment planning for radioimmunotherapy, radiopeptide therapy, and radiopharmaceutical therapy.

Federal Funding for Neuroendocrine Tumor Research
SNMMI successfully advocated for the inclusion of neuroendocrine tumors on the list of conditions eligible for dedicated research funding through the Department of Defense’s Congressionally Directed Medical Research Program’s Peer Reviewed Cancer Research Program. In August, the Senate Appropriations Committee recommended $130 million for this program in its FY25 Defense Appropriations Report, enabling expanded research into therapies for neuroendocrine tumors.

“SNMMI is dedicated to bringing theranostics to all those who can benefit from it,” said Cutler. “We look forward to sharing our research, standards, guidelines, and educational resources with nuclear medical professionals worldwide. As clinical use of theranostics continues to grow, we are eager to collaborate with international nuclear medicine societies to bring this medical innovation to patients across the globe.”

About the Society of Nuclear Medicine and Molecular Imaging

The Society of Nuclear Medicine and Molecular Imaging (SNMMI) is an international scientific and medical organization dedicated to advancing nuclear medicine and molecular imaging—vital elements of precision medicine that allow diagnosis and treatment to be tailored to individual patients in order to achieve the best possible outcomes.

SNMMI’s members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals and meetings and leading advocacy on key issues that affect molecular imaging and therapy research and practice. For more information, visit www.snmmi.org.