When Imaging Becomes the Bottleneck
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When Imaging Becomes the Bottleneck
Radiopharmaceutical development depends on imaging.
It identifies the right patients, guides treatment decisions, and measures how well therapies are working. As more Theragnostic therapies move into clinical trials, imaging is no longer a supporting step. It is central to how these trials are designed and executed.
And increasingly, it is becoming a constraint.
Imaging Demand Is Rising Faster Than Capacity
The use of Theragnostics is expanding quickly. Imaging agents such as ⁶⁸Ga-PSMA and ⁶⁸Ga-DOTATATE are now routinely used to identify patients for targeted treatments like ¹⁷⁷Lu-PSMA and ¹⁷⁷Lu-DOTATATE [1].
Each of these therapies depends on imaging at multiple stages.
Patients must first be scanned to confirm that their tumors express the appropriate target. Many trials then require repeat imaging during treatment to assess response or support dose planning. This creates sustained demand for PET and SPECT imaging.
Recent analyses show that this demand is growing faster than the infrastructure and workforce needed to support it [2][3].
Imaging departments, which already manage routine clinical care, are being asked to absorb additional demand from clinical trials.
Capacity is not scaling at the same rate.
Imaging Is Embedded Across the Trial
In traditional oncology trials, imaging is often treated as a single step. In radiopharmaceutical development, it is part of the entire patient journey.
Imaging determines eligibility. It informs treatment decisions. It supports ongoing assessment of response. Regulatory guidance emphasizes the need for consistent, high-quality imaging to evaluate these therapies [4]. This increases both importance and complexity.
Each scan requires coordination between nuclear medicine, radiology, and clinical trial teams. Variability in scanner availability, imaging protocols, and radiotracer supply can all affect execution.
Imaging has become a continuous requirement.
Capacity Constraints Are Operational, Not Just Technical
The limitation is not simply the number of scanners. Imaging capacity depends on a broader system that includes trained personnel, workflow efficiency, radiotracer access, and the operational systems that connect them. When those systems are outdated, they can limit a site’s ability to perform the functions required to develop, deliver, and evaluate radiopharmaceuticals effectively.
Radiopharmaceutical imaging requires specialized staff, including technologists, physicians, radiopharmacists, and physicists. It also depends on radiotracers that must often be produced and delivered within strict time windows.
Workforce shortages are already affecting imaging throughput and increasing wait times [5][6]. At the same time, the expansion of radiopharmaceutical therapy is expected to require more trained staff and more capable clinical sites [3].
Global health organizations highlight that access to nuclear medicine depends on infrastructure, workforce, regulatory systems, and supply working together [7].
This creates variability across sites.
Two sites may have similar equipment but very different ability to support complex trial protocols. Staffing, scheduling, and coordination determine how imaging capacity is realized in practice.
Trial Design Is Increasing the Burden
Radiopharmaceutical trials are placing greater demands on imaging.
Protocols often require multiple baseline scans, standardized acquisition parameters, central image review, and repeated imaging across treatment cycles.
These requirements are necessary to generate reliable and comparable data. They also increase operational burden. Scheduling becomes more complex. Scan times may be longer. Imaging teams must coordinate closely with treatment teams to meet protocol requirements.
Even well-equipped sites can reach capacity limits under this level of demand.
The Bottleneck Reflects a System Constraint
Imaging constraints do not exist in isolation, they interact with other parts of the clinical trial system.
A delay in imaging can slow patient enrollment, shift treatment schedules, and delay data collection. Implementation studies show that successful Theragnostic programs depend on coordination across imaging, therapy delivery, infrastructure, and workforce [8].
Imaging becomes the visible pressure point, but the underlying issue is broader. It reflects how well the full system is aligned to support radiopharmaceutical development at scale.
Theragnostic Insight - Imaging capacity reflects the strength of the broader Theragnostic system. Planning must account for workforce, workflow, and infrastructure together to support consistent execution.
What This Means for Sponsors and Health Systems
For sponsors, imaging should be evaluated early in development planning. This includes assessing site-specific capacity, understanding radiotracer access, and aligning protocol requirements with real-world workflows.
For health systems, the growth of Theragnostic therapies presents both opportunity and strain. Expanding imaging capacity requires investment in equipment, workforce, training, and coordination.
Without this alignment, imaging becomes a limiting factor in delivering advanced therapies.
What This Means for You
Radiopharmaceutical development is advancing quickly, but supporting systems are still scaling.
Imaging sits at the center of this challenge.
Understanding how imaging capacity interacts with clinical operations is essential for realistic planning and successful execution.
At Theragnostic Insights, we help teams evaluate these system-level dependencies early and align development strategy with operational reality.
Because in radiopharmaceutical trials, progress depends on more than the therapy. It depends on the systems that enable it.
Stay tuned for more in this mini-series: Clinical Capacity Crisis: The Hidden Bottleneck in Radiopharma Development.
In the coming weeks, we’ll continue exploring the clinical capacity crisis holding back radiopharmaceutical innovation, from regional access gaps to operational gridlock and infrastructure blind spots. Don’t miss the next post as we map out the road to a truly trial-capable ecosystem.
- The Trial Site Gap: Why Radiopharmaceutical Innovation Is Hitting a Wall
- Geography Is Destiny: The Clinical Access Gaps in Radiopharmaceutical Research
- Operational Gridlock: Where Radiopharmaceutical Trials Break Down on Site
- Beyond the Badge: Rethinking What “Trial-Ready” Really Means in Radiopharma
- Infrastructure as Investment Strategy: Clinical Site Access and Radiopharma ROI
- Built for What’s Next: Redefining Clinical Site Design for Theragnostic Trials
- Speed as Strategy: How Site Scarcity Is Slowing Radiopharmaceutical Pipelines
- One Roof, Many Bottlenecks: Why Fragmented Site Models Undermine RLT Trials
- The Dosimetry Dilemma: Why Many Sites Aren’t Ready for Radioligand Trials
- Licensing & Radiation Safety: The Regulatory Maze Behind Radiopharmaceutical Trials
- The Hidden Role of Radiation Safety in Clinical Trial Activation
- The Radiopharma Workforce Gap: Who’s Actually Running These Trials?
- The Infrastructure Nobody Funds: Why Clinical Trial Sites Are Missing From Radiopharma Investment
- Manufacturing vs. Clinical Sites: The Missing Investment in Radiopharma Development
- Why Radiopharma Trial Timelines Are Harder to Predict Than Traditional Oncology Trials
- When Imaging Becomes the Bottleneck
References:
[1] Zhang et al., 2025. Radiopharmaceuticals and their applications in medicine. Signal Transduction and Targeted Therapy.
[2-5] The Lancet Oncology, 2024. Advancing Theragnostics and nuclear medicine infrastructure. The Lancet Oncology.
[3-6] Journal of Nuclear Medicine, 2025. Radiopharmaceutical therapy expansion and workforce needs. Journal of Nuclear Medicine.
[4-3] European Medicines Agency, 2024. Concept paper on the clinical evaluation of therapeutic radiopharmaceuticals in oncology. EMA.
[5-4] Journal of Nuclear Cardiology, 2025. Workforce shortages and imaging capacity constraints. Journal of Nuclear Cardiology.
[6-7] American Society of Radiologic Technologists, 2024. Medical imaging workforce shortage white paper. ASRT.
[7-2] International Atomic Energy Agency, 2024. Nuclear medicine in therapy and diagnosis. IAEA.
[8] Al Ibraheem et al., 2025. Implementation of Radiotheranostics: Challenges, Barriers, and IAEA Driven Strategies for Sustainable Access. Seminars in Nuclear Medicine.
https://www.nature.com/articles/s41392-024-02041-6
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00037-8/abstract?
https://jnm.snmjournals.org/content/early/2025/10/23/jnumed.125.271028?
https://www.journalofnuclearcardiology.org/article/S1071-3581(25)00401-5/abstract?
https://www.sciencedirect.com/science/article/abs/pii/S1470204524000378?
