Highlights from TRP EU and EANM 2025

This year’s Targeted Radiopharmaceuticals Summit Europe (TRP EU) congress (held 10 – 12 November in Amsterdam, the Netherlands) and European Association of Nuclear Medicine (EANM) congress (held a few weeks before on 4 – 8 October in Barcelona, Spain) were full of innovation. PSI’s Director of Project Management Lucy Knight, Senior Director of European Business Steven De Hertefelt, and Clinical Trial Liaison Rohit Kumar Nath attended; read on for their takeaways from both congresses and how these impact our sponsors and their clinical trials.

Collectively, over 10,000 participants and more than 250 speakers from around the world gathered across the two congresses in Europe to discuss the latest developments in theranostics and diagnostics, innovations impacting the clinic (including changing dose optimization guidance from the FDA), and the role that AI will play in 2026 and beyond. The crucial role that the CRO provides in generating data from radiopharmaceutical trials was also covered in Lucy Knight’s TRP EU presentation on evidence-based challenges during radiopharmaceutical clinical trials. Here, we consider how the research presented during both congresses will impact sponsors and the radiopharmaceutical clinical trials of the future.

Discoveries in theranostics

Advances in theranostics: At the heart of EANM was theranostics, precision medicine, which, in the context of cancer, identifies and images the cancer cells, diagnoses and therapeutically treats the tumor. PSMA- and SSTR-based therapies continue to demonstrate prolonged progression-free survival in patients with advanced prostate and neuroendocrine tumors. Emerging ligands targeting HER2, Nectin4, and CXCR4 extend the reach of theranostics to breast, lung, and gynecological cancers, and beyond (for example, endometriosis). Preclinical data of novel 64Cu agents showed prolonged survival in glioblastoma models; human translation is imminent.

Alpha-emitters to the forefront: Across both congresses, the debate about alpha- vs. beta-emitters (or both in combination) took center stage. Compelling results from alpha-emitter trials showed remarkable responses in micro-metastatic and PSMA-resistant disease. Short-lived alpha-emitter therapy could be delivered in the outpatient clinic. At TRP EU, a new paradigm was presented: Compartment-restricted alpha therapy. This receptor-independent radioligand therapy was presented in peritoneal metastasis and ovarian cancer and is driven by anatomical containment. CROs need to be prepared for more trials with alpha-emitters (perhaps 225Ac at first) – sites need training to build expertise, particularly in imaging. Support networks and regulatory guidance will help in managing the supply chain. Disposal logistics should be carefully considered – alpha-emitters with long-lived impurities may require licensed radioactive waste disposal, rather than decaying on-site.

Highlighting truly personalized medicine: Precision medicine was highlighted – the EANM Dosimetry Committee emphasized patient-specific dosimetry at organ (and smaller) levels, ensuring that theranostics adheres to the same standards of quantification and safety as external beam radiotherapy. AI is also helping to enable truly personalized radionuclide therapy – advances in 177Lu and 225Ac PSMA protocols showcased AI-assisted dosimetry and adaptive treatment planning.

In clinical trial operations, theranostics are a balance: A more targeted and personalized approach to treatment leads to higher efficacy rates and improved patient outcomes, but comes with increased logistical and operational complexity due to advanced imaging techniques and isotope transport. Relying on specialized infrastructure and multidisciplinary teams, including imaging and dosimetry specialists, is the only way to streamline radiopharmaceutical clinical trials and meet milestones on time.

Innovation brings investment. The big pharmaceutical companies invested over $10 billion in just eight months last year for four radiopharmaceutical companies[1]. We haven’t seen signs that the investment is slowing down – we expect a surge to nearly $10 billion dollar revenues in 2031. Therapeutic agents are seen as the high-growth, high-reward area, attracting significant capital for next-generation cancer treatments. Investments in diagnostics focus on pairing diagnostic agents with therapeutic ones, not on standalone diagnostic agents being developed. Great progress is being made with diagnostic agents outside of oncology, such as in CNS and women's health - so we look forward to exciting radiopharmaceutical developments in the next few years.

Steven De Hertefelt, Senior Director, Business Development, PSI

Innovation – isotopes, antagonists, tumor microenvironment, and the FDA

Emerging paradigms: One thread running through the scientific sessions at EANM was the remarkable progress in molecular targeting – the shift from classic isotopes to multifunctional products is very clear – and is best described through three key principles:

  • Improving specificity
  • Reducing toxicity
  • Extending applications beyond oncology

Significant advances from universities in Germany (18F used to visualize tumor senescence and resistance mechanisms), and China (68Ga/177Lu dual agents targeting Nectin4 for triple-negative breast and bladder cancers and targeting PD-L1 in combination with immunotherapy). Further highlights included 68Ga mesothelin-targeting probes for early ovarian and pancreatic cancer detection, one of the first comparative cytotoxicity studies (161Tb vs 177Lu in micrometastatic disease), and 77Br for neuroendocrine and lung cancer. New studies in inflammation and infection imaging suggest an expanding role for nuclear medicine beyond oncology.

Beyond the change to using nuclear medicine as a first-line strategy for cancer, RLT application in neurodegenerative and cardiovascular disease, inflammatory conditions, women’s health and infections means a larger quantity of isotopes will be required. Large-scale isotope production remains a key limitation yet to be solved.[2] Beyond improving production technology, international cooperation would help ensure a stable isotope supply, including improving government funding and supportive policies, and modernizing or streamlining regulatory requirements.

Radiopharmaceuticals are still in the early days of discoveries, and their potential is immense. Bridging multiple disciplines, from medical imaging and nuclear medicine to pharmacy and chemistry, the integration of these fields is opening up new frontiers in both diagnostics and treatment. I think we're really at the cusp of something transformative. As research and technology continue to evolve, we may see radiopharmaceuticals become a staple in clinical practice, not only for diagnostics but as a cornerstone of precision medicine. The way they are poised to revolutionize healthcare is truly remarkable.

In discussion with Rhonda Critchlow, Head, Specialized Study Support Services, PSI

Moving from agonists to antagonists: Thus far, most ligands tend to be agonists; however, as our understanding of cancer receptor biology increases, trends in research and development showcased at TRP indicated a strong and decisive shift to antagonists. Antagonists:

  • Bind active and inactive receptors, leading to a higher maximum number of binding sites
  • Remain surface-bound (ideal for alpha emitters)
  • Have high tumor retention

For example, SSTR2 antagonists were shown to have higher binding affinity, longer residence, and superior tumor uptake in comparison to DOTATATE.[3],[4] SSTR antagonists are in commercial development phases with different radioisotopes, so CROs should expect upcoming phase 2 and 3 trials.

Targeting the microenvironment: Strategies to target the tumor microenvironment remain paramount: Overcoming drug resistance, blocking tumor progression and metastasis, and enhancing the patient’s immune system to complement the radiopharmaceutical are key to prolonged patient survival. Advances in targeting the tumor microenvironment presented at TRP EU included a new pharmacological class, hydroxyl dendrimers (inflamed cells, including microglial cells, absorb the dendrimers, which are coupled with radioligands to enable targeted therapy), and an exploration of nanocarrier strategies for hard-to-reach tumor beds. Providing support for complex (neuro)radiopharmaceutical trials is on the horizon for CROs.

Changing guidelines: The FDA’s draft guidance on optimal dosage for radiopharmaceutical therapies in oncology, released in August,[5] was a hot topic at both EANM and TRP EU. While EBRT tolerance removals will theoretically speed up clinical trials from planning to completion and reduce reliance on animal models in favor of AI-related dosimetry modelling, central dosimetry (and patient-specific dosimetry) must also increase to meet potential demands. Sponsors must therefore think longitudinally. Choosing a CRO with expertise in radiopharmaceutical studies (including operationalizing training programs and guidance documents), and significant project management experience of complex, fast-moving, logistics-heavy trials to meet their expectations. CROs should also prepare for more real-time dosing adjustments needed within trials, as designs become more flexible and more dose-responsive.

One key expectation with the FDA’s updated guidance is that approved therapies will expand to oncological and neuro-radiological applications at a much faster pace than previously anticipated.  We also expect more radioligand therapy trials led by nuclear medicine specialists, rather than oncologists. Shared decision-making and collaboration between specialties will become more important than ever before

Rohit Kumar Nath, Clinical Trial Liaison, Specialized Study Support Services, PSI

Developments in AI

Dominating the EANM agenda, AI underscores how data science rapidly reshapes every stage of nuclear medicine. Highlights included:

  • Convolutional neuronal networks trained on large multicenter datasets achieve near-human accuracy in [18F]FDG and [68Ga]PSMA imaging, reducing contouring time by >70%

  • Structured-reporting tools integrate quantitative imaging metrics, such as SUV (standardized uptake value), MTV (metabolic tumor volume), and TLG (total lesion glycolysis) with EMRs to generate AI-assisted diagnostic and prognostic reports

  • Commercially developed deep-learning frameworks halve PET scan time without loss of image quality, and allow real-time dynamic reconstruction for kinetic imaging

AI can accelerate trial design and data evaluation by enabling automated lesion segmentation, dynamic response assessment, and improved dosimetry modeling, ultimately enhancing both precision and reproducibility in multicenter studies. Incorporating AI-driven analysis into trial protocols, including data standardization, validation, and interoperability (in combination with clinician validation), is a regulatory and technical challenge that an experienced CRO is capable of helping the sponsor to overcome.

Operational realities of radiopharmaceutical clinical trials

As part of the TRP EU’s first session (“A booming radiopharmaceutical landscape: Evaluating the progress of TRPs in Europe and beyond”), PSI’s Lucy Knight delivered a well-attended seminar on the practical implementation and key challenges of radiopharmaceuticals in clinical trials. Key recommendations include:

  • Manage the radioactive therapeutic and/or diagnostic IPs
    • Manufacturing, ordering, shipment, handling, scanning, and dosing require dedicated time and considerable organization. Customized IRT, site specific tools, treatment room capacity and aligned dosing days are crucial
  • Provide specialist support
    • The CRO project team must contain imaging and dosimetry specialists, trained in camera qualifications and qualified in radiologic science, or certified as nuclear medicine technologists
  • Facilitate site logistics
    • Asking the right questions early is key. CRAs need to be experienced coordinating interactions between oncology (or other fields) and nuclear medicine physicians, nuclear medicine technicians, medical physicists and the imaging department or off-site facility to ensure suitability of equipment, that radiation limits are not exceeded, and supportive medicines are available
  • Ensure on-time enrollment
    • Tracking every potential participant to understand when they will be able to start screening, have their imaging scan and receive their first therapeutic dose is essential. Educational tools assist investigators with complex discussions during the consenting process. Regular meetings with site staff allow emerging data and operational recommendations to be shared
  • Manage additional complexity
    • Consider the unique risks when monitoring radiopharmaceutical trials – tailored comprehensive monitoring and risk management plans are essential. There must be clear guidance on data entry for specific departments and an understanding regarding local practice

Matching the needed procedures to the variable time window between manufacture and dosing is a skill. It is important to be on time, every time. The difference is made in the trial planning phase – involving CROs early to allow time to implement proper risk mitigation strategies helps ensure smooth progress of sponsor trials.

Lucy Knight, Director, Project Management, RLT Programs, PSI

Hear more about the key challenges and practical solutions when running radiopharmaceutical clinical trials in Lucy’s upcoming webinar by enrolling

here.

In summary

Findings across both TRP EU and EANM were numerous; however, these key takeaways contribute to evolving trends in radiopharmaceuticals and help prepare sponsors, CROs, and trial participants for the future. Whether a difficulty with a new theranostic, or an operational hurdle with a TME-targeting radioligand or AI imaging framework, running clinical trials in such a challenging, fast-paced, and complex therapeutic area requires partnering with the right CRO – the CRO that has the experience in delivering pivotal global radiopharmaceutical studies and in the problem-solving needed to keep you on track.

Nuclear medicine is not just advancing – it is accelerating. 

Learn more about PSI's radiopharmaceutical experience and solutions today.

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Abbreviations

AI, artificial intelligence;
CRA, clinical research associate;
CXCR4, C-X-C chemokine receptor type 4;
EANM, European Association of Nuclear Medicine;
EBRT, external beam radiation therapy;
EMR, electronic medical record;
FDA, Food and Drug Administration;
FDG, flourodeoxyglucose F18;
MTV, metabolic tumor volume;
HER2, human epidermal growth factor receptor 2;
IRT, interactive response technology;
PD-L1, programmed death-ligand;
PET, positron emission tomography;
PSMA, prostate-specific membrane antigen
RLT, radioligand therapy;
SSTR2, somatostatin receptor 2;
SUV, standardized uptake value;
TLG, total lesion glycolysis;
TME, tumor microenvironment; 
TRP, targeted radiopharmaceutical; 
TRP EU, Targeted Radiopharmaceuticals Summit Europe.

References

1. 2025 forecast: As companies rush to radiopharmaceuticals for oncology, what’s next? Available from https://www.fiercepharma.com/pharma/2025-forecast-companies-rush-radiopharmaceuticals-oncology-whats-next, accessed November 2025.
2. Giammarile F., et al. Lancet Oncol. 2024;25(6):e260-e269.
3. Imperiale A., et al. J Nucl Med. 2023;64(5):682-684.
4. Ahenkorah S., et al. Nucl Med Biol. 2023;118-119:108338.
5. Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development; Draft Guidance for Industry; Availability. Available from https://www.regulations.gov/docket/FDA-2025-D-1757, accessed November 2025.