Advancing Theranostics in Oncology Through Nuclear Medicine
We were delighted to welcome Dr. Paredes to our Fortrea Barcelona offices, where she gave an insightful talk about her work at Hospital Clinic in Barcelona. As a consultant in the Nuclear Medicine Department and investigator in clinical studies focused on theranostics—a rapidly evolving field in oncology—Dr. Paredes shared valuable perspectives on the integration of diagnostics and targeted therapies. She also generously agreed to sit down for an interview with our VP of Oncology, Dr. Laura Vidal, where we explored the promise of theranostics and the practical challenges clinical sites face in making this innovative approach more accessible to patients.
What are two or three key challenges encountered during the theranostic work-up in an academic hospital setting?
“The first and perhaps most significant challenge,” Dr. Paredes began, “is resources. Most academic hospitals simply do not have the infrastructure needed to run clinical trials with radioligands. We see a lack of dedicated facilities for managing radioactive waste and not enough rooms available to safely treat patients. To address this, many hospitals are now developing outpatient day care units. These units are designed to ensure proper patient care during both the infusion and the subsequent radiological protection period.”
She continued, “Secondly, coordination between departments is a major hurdle. Implementing theranostic protocols really does require close collaboration from a multidisciplinary team. We often find ourselves navigating silos, and achieving seamless cooperation can be quite challenging. This is an area that certainly warrants deeper discussion.”
“Finally,” Dr. Paredes added, “there is the issue of personnel training. Those with experience in clinical trials often lack the necessary background in radiation safety and the management of radioactive contamination. On the other hand, staff who are well trained in handling radiopharmaceuticals may have little or no exposure to clinical research processes. As a result, we have invested substantial effort in training nuclear medicine professionals, nurses, and other oncology staff in the principles of radiation safety and radiological protection, in order to build a more integrated and capable team.”
Beyond these internal challenges, Dr. Paredes pointed out that administration and regulatory frameworks present an additional layer of complexity. “Some countries have more relaxed legislation regarding the use of radioligands, making the path to implementation smoother,” she explained. “In others, Spain being a prime example, the laws are considerably more restrictive. For this reason, we can consider differing legislation across countries as a fourth key challenge when advancing theranostics within academic hospital settings.”
How does the lack of dedicated infrastructure—such as radiopharmacy facilities or advanced imaging capabilities—affect the development of theranostic clinical studies? How are sites managing those?
“Most academic hospitals have to depend on their own resources”,Dr Paredes replied, “often pulling from research funds or alternative financial sources, to create the necessary infrastructure. For example, establishing appropriate radioactive waste facilities is essential, but without dedicated funding, this can be a significant hurdle.”
Having an on-site GMP (Good Manufacturing Practice) facility as a requirement by some regulators such in Spain can limit or even exclude some well-established centers from participating in theranostic research because not every institution can support this level of infrastructure. Therefore, what multiple sites are doing is “to source radiopharmaceuticals from a centralized radiopharmacy. This allows multiple sites to receive supplies from a single batch, which not only helps reduce costs but also ensures consistency in product quality. Although scheduling is certainly a factor to be considered in clinical studies, that does not differ significantly from the use of diagnostic radiopharmaceuticals”
Imaging is used for selecting patients for inclusion in trials and for dosimetry measurements. While academic centers are equipped to perform dosimetry imaging, this process can significantly reduce gamma camera availability for routine clinical work.
Based on your experience, what would you say is the main challenge or obstacle in ensuring smooth coordination between the Nuclear Medicine Department and Oncology units when conducting a theranostic clinical study?
“One of the main differences with other oncologic studies is that the radioactive drug must be administered under the supervision of a nuclear medicine physician. Unlike conventional treatments, radiopharmaceuticals can’t be stored on-site for long periods—they have to be delivered on the exact day of administration or the day before. And since production is limited to specific days of the week, all study-related procedures—blood tests, urine samples, ECGs, patient visits—need to be carefully scheduled around that treatment day”
This means the Nuclear Medicine Department becomes the starting point of the entire study workflow, and that’s where “we often face the greatest logistical challenges. Clinical trial units are typically used to scheduling visits based on the availability of the principal investigator, the oncologist. But in theranostics, the timing is dictated by radiopharmaceutical delivery and nuclear medicine capacity.”
In Dr Paredes view, “one practical solution would be to appoint a dedicated study coordinator within the Nuclear Medicine Department. That person would work closely with the oncology study coordinator to align and synchronize the patient’s journey. This kind of structural adjustment is exactly what departments may need to consider if they want to support the expansion of theranostics and ensure that patients can benefit from these innovative therapies”.
What regulatory challenges tend to delay or complicate the implementation of theranostic clinical studies ?
“As I mentioned earlier, current legislation varies significantly across countries. In most cases, radiopharmaceuticals are regulated similarly to conventional drugs. However, their radioactive nature introduces additional layers of complexity, and more restrictive regulations often apply. Within the European Union, there’s considerable disparity between member states in how these compounds are handled.”
“One of the main regulatory hurdles”, Dr Pareded continued, “lies in the use of certain radioactive isotopes, as well as the requirements around chain of custody and radioactive waste disposal. When a trial involves radiopharmaceuticals containing isotopes that are already approved and widely used—such as Gallium-68 or Lutetium-177—the approval process tends to follow a more familiar pathway, similar to that of other oncology drugs. However, when less common isotopes are used, such as Actinium-225 or Terbium-161, the regulatory process can be significantly delayed due to the need for additional safety evaluations and infrastructure considerations. These differences can create real obstacles for trial activation and patient access, especially when trying to harmonize protocols across multiple countries”.
There's a growing use of the term nuclear oncologist in the context of theranostics. What are your thoughts on this designation? How you foresee your role in theranostics clinical development?
Dr Paredes provided her view on the term nuclear oncologist. “As a nuclear medicine physician actively involved in radiopharmaceutical studies, I strongly believe our role needs to come to the forefront. We should be leading clinical trials at the same level as other specialists, such as oncologists or urologists. Theranostics is not just a technical field—it’s a clinical one, and nuclear medicine must be recognized as a central player in patient care and research”.
That said, she believes they still have a long journey ahead. “Many nuclear medicine specialists have become accustomed to working behind the scenes, focusing on imaging and interpretation. To truly fulfill the potential of theranostics, we need to reclaim our foundational skills in direct patient management. We must step out from behind the screens and return to face-to-face patient care—engaging with patients, guiding treatment decisions, and taking ownership of the clinical journey. This shift is essential if we want to be seen not just as technical contributors, but as clinical leaders in the evolving landscape of personalized oncology.” Nevertheless, the cornerstone for success in these clinical trials is close collaboration with other disciplines, primarily oncology, but also radiation oncologists, urologists, …