Theranostics Trials in Oncology: Essential Capabilities for Sponsors
Explore why theranostics trials in oncology are complex and the key CRO capabilities that help sponsors succeed from start to finish.
Theranostics is reshaping oncology by combining targeted diagnostics with precision therapeutics. A diagnostic tracer identifies tumors, while a therapeutic isotope delivers treatment to those same sites, enabling earlier detection, tailored dosing and real-time monitoring. It’s an approach that personalizes care, reduces unnecessary exposure to ineffective therapies and helps patients access treatment matched to their unique biology.
Planning a theranostics trial? Discover what to expect from your CRO partner.
But the science is moving quickly. Regulatory requirements are demanding, operational logistics are unforgiving and only a limited set of sites worldwide are prepared to manage the dual diagnostic and therapeutic workflows a theranostics clinical trial requires.
For sponsors, the right CRO partner can make the difference between a trial that advances personalized cancer care and one that stalls under operational pressure.
Why Are Theranostics Trials So Complex?
Theranostics may be one of oncology’s most promising frontiers, but it introduces hurdles that traditional studies rarely face. From regulatory scrutiny to site readiness and isotope logistics, sponsors must anticipate challenges that can derail timelines if not managed with precision.
Regulatory complexity remains the first obstacle. Radiation dosing demands meticulous planning and justification, and regulators expect clear safety protocols to minimize risk. Because dosing is often individualized to each patient, agencies also require sophisticated modeling — a step that, if mishandled, can trigger costly amendments or even study holds. Adding to the challenge, no two agencies take the same approach; what passes at FDA may require additional justification for EMA, and APAC regulators have frameworks of their own.
Site readiness is another major barrier. Not every oncology site is equipped for theranostics. Many lack the infrastructure or approvals to handle isotopes safely, while others may not have experience running dual diagnostic-therapeutic workflows. CRO partners need to be able to pre-qualify nuclear medicine sites and, often, deliver trial-specific training to bring them up to standard.
Finally, logistics can make or break a trial. Because many isotopes decay within hours, supply chains must run flawlessly. Short half-lives leave no room for error across customs, cold chain or cross-border transport. Even minor delays can result in unusable doses, wasted product and rescheduled patient visits — frustrating for both patients and sponsors, and costly to the trial overall.
What Should Sponsors Expect From a CRO Partner?
The right CRO will go above and beyond to help de-risk these challenging studies. Sponsors should expect:
- Regulatory foresight: Proven expertise in radiation dose modeling, cross-border filing strategy and harmonizing protocols across agencies.
- Site activation expertise: Access to global networks of nuclear medicine centers with theranostics-ready infrastructure, plus the ability to qualify and train new sites quickly.
- Operational precision: Tested capabilities in radioactive material shipping, isotope decay tracking, customs clearance and time-critical logistics. These skills are not widely distributed; CRO partners should be able to prove they’ve done it before.
Why Regulatory Strategy Determines Success
Sponsors that underestimate the regulatory dimension of theranostics often find themselves stuck in costly cycles of revision. Protocols must anticipate scrutiny on dosing methodology and radiation safety from the start. CROs with global experience in filings and audits can:
- Reduce the risk of amendments by building compliant, flexible protocols upfront.
- Accelerate trial startup by aligning submissions across multiple geographies.
- Ensure audit readiness by embedding documentation standards into trial workflows.
The Global Site Equation
Site selection is another major challenge. While oncology sites are plentiful, only a fraction can safely and effectively participate in theranostics trials. Sponsors should look for CRO partners that can:
- Identify nuclear medicine centers with proven capacity for both diagnostic imaging and therapeutic delivery.
- Ensure isotope-handling approvals are in place and compliant with local and international regulations.
- Support training and infrastructure development for sites new to theranostics.
By expanding the global pool of qualified centers, CROs can help speed trial startup by giving sponsors more flexibility in recruitment and patient diversity.
Logistics: Where Trials Win or Lose
Few operational hurdles are as unforgiving as isotope logistics. Unlike traditional oncology drugs that can be manufactured, packaged and stored over time, theranostics agents are perishable. Sponsors should expect their CRO partner to:
- Coordinate with isotope suppliers, customs authorities and couriers in real time.
- Manage redundant pathways and contingency planning for border closures or transport disruptions.
- Monitor decay curves and patient scheduling simultaneously, ensuring every dose arrives viable and on time.
Strategic Considerations for Sponsors
Theranostics is one of oncology’s most promising frontiers as well as one of the most complex to operationalize.
The right CRO partner will bring regulatory insight to anticipate scrutiny and avoid delays, site networks equipped for dual diagnostic-therapeutic workflows and logistical expertise to manage radioactive isotopes with precision.
With this support, sponsors can accelerate timelines, reduce risk and deliver the next wave of personalized cancer care to patients faster.
Have questions about theranostics trial design or operations? Connect with our experts.
Contributors
Daniel Mazzolenis | SVP, Medical Management
Jozsef Palatka | VP, Medical Management
David Pereira | Senior Medical Director
Related Content
Looking for exclusive insight?
