The current landscape of early phase oncology clinical trials is very active, to say the least. With substantial research and development investment, early phase oncology clinical trials are currently yielding encouraging insights and success stories, including accelerated approvals and promising new treatments. From targeted immuno-oncology therapies to novel radiopharmaceutical therapies, phase 1 oncology trials are delivering more meaningful, strategy-shaping signals than ever before. To explore the evolving area of early oncology research, we are sharing insights from Dr. Oliver Bohnsack, Vice President Medical Imaging and Head of Oncology Imaging at Perceptive. His over 20 years of industry experience and strong academic achievements have helped to shape the field. Complimenting his expertise, Joseph Vacca, Vice President of Solutions, will speak directly to the emerging area of radiopharmaceuticals.
Imaging plays a central role in early-phase oncology research. Imaging endpoints have evolved from the more definitive endpoint of overall survival, to include surrogate measures such as response assessment, overall response rate, and progression-based endpoints like progression-free survival. These early and evolving indicators of therapeutic activity help sponsors make sound Go – No Go decisions for further treatment development, and help regulators to gauge the potential efficacy of novel treatments, providing the evidence needed to grant accelerated approval, particularly in areas of unmet need. While surrogate endpoints are not a replacement for overall survival, which may take many years to evaluate, well-validated imaging endpoints can support these accelerated pathways by providing early signs of efficacy and clinical benefit to justify ongoing development. Imaging plays a central role in this process, yet it can often be overlooked, Dr. Bohnsack explains.
“Over my 22 years in this industry, the landscape has shifted dramatically. One challenge we see time and time again is that medical imaging is often underestimated. Trials are designed with imaging-based endpoints, but the operationalization of imaging is neglected, something you simply can’t do,” says Dr. Bohnsack. “Many sponsors rely on imaging results but invest very little in proper data acquisition. It’s essential to bring an imaging core lab into the study early, ideally during program development, to ensure data collected is robust and reliable and ready for regulatory submission.”
In modern-day oncology clinical trials, it is not always ethical to test developmental compounds on healthy volunteers, as agents can be cytotoxic or immunomodulatory. With precision medicine changing the face of oncology research, compounds are often targeted to the specific disease entities and tumor cells, meaning their activity and safety can only be meaningfully evaluated in patients who express those molecular targets. This shift has direct consequences for all imaging decisions, taking into consideration underlying disease biology, target expression, and the identification of measurable lesions.
“What used to be tested in healthy volunteers now increasingly begins with patients, particularly in the context of genetic research and targeted therapies,” explains Dr. Bohnsack. “First-in-human often means first-in-patient, which fundamentally changes how sponsors must think about safety and efficacy, and how to determine imaging endpoints.”
When early research moves directly into patient populations, imaging endpoints become a balance between determining safety and tolerability, while simultaneously capturing early signals of biological activity. Outcome assessment becomes patient-centric and must be integrated with disease management. Often, the risk-benefit threshold is different for patients with existing disease, and disease-related events must be differentiated from drug-related events, toxicities, and side effects of that very treatment. Imaging endpoints shift from baseline safety readouts to more nuanced, early indicators of efficacy, with a potential future outlook to later-stage trials and accelerated approvals. Imaging endpoints and trial design must be flexible, replacing traditional dose-escalation models with adaptive model-based designs.
Radiopharmaceuticals represent a paradigm shift in early oncology development, combining a radioactive isotope with a targeting molecule to deliver precision radiation therapy directly to cancer cells. Variation from traditional early phase oncology clinical trials covers mechanism of action, theranostic capabilities, and differences in pharmacokinetics, distribution, and toxicity. “Rather than relying on cellular uptake like traditional cytotoxic or even targeted therapies, radiopharmaceutical agents deliver radiation directly to cancer cells, utilizing a fundamentally different mechanism of action to deliver highly selective tumor control,” explains Joseph Vacca, Vice President of Solutions, Radiopharmaceuticals.
“Radiopharmaceutical compound behavior is governed by radioisotope decay, biodistribution, and clearance patterns, which differ significantly from traditional drugs, often having lower systemic toxicity due to targeted delivery, but requiring careful management of radiation exposure and off-target effects.”
With operational and regulatory logistics spanning site qualification, half-life considerations, lack of standardized site setup / dose calibration, and dosimetry / imaging optimization, tight coordination is needed between supply chains and clinical sites, with most sponsors finding a central imaging hub essential for effective radiopharmaceutical trial management. “Nuclear medicine has truly been in our DNA since the company’s inception,” says Vacca. Through partnerships with highly-specialized service providers like Radialogica, Voximetry, and RAPID, Perceptive works to ensure standardized radiotherapy protocols, reducing variability and enhancing trial reliability in both EBRT and RPT programs.
Perceptive has built a robust, end-to-end infrastructure tailored to the evolving demands of both early phase oncology and radiopharmaceutical clinical trials. “We manage the entire logistics chain for imaging, including data collection, quality control, and image analysis. Without an imaging lab, the sponsor would need to handle all of this themselves,” explains Dr. Bohnsack. Ultimately, someone has to take responsibility for the integrity of the imaging data.
“An imaging lab provides blinded, independent central reads, something that simply can’t be achieved at the site or hospital level. Robust, reproducible image analysis can only come from a dedicated imaging lab or from an exceptionally well-managed radiology–oncology department.”
At Perceptive, we have the experience, knowledge, and infrastructure to manage every aspect of phase I oncology trials and beyond when it comes to supporting submissions, taking into consideration the evolution of imaging endpoints and aligning imaging services with specific patient populations, offering adaptable tiered services to ensure sponsors get the exact level of support needed. “Our experts don’t just read CT and MRI scans, they handle functional imaging and advanced image analytics, extracting the precise data sponsors need.” With a team that has long-standing tenure in this work, we can deliver robust, reliable Oncology CRO services across the full spectrum of early phase oncology imaging studies.
“We encourage emerging biotech companies to reach out, there’s no harm in asking whether central imaging is necessary for a trial,” concludes Dr. Bohnsack. “If it isn’t, we’ll happily say so. We can start with a simple ‘collect and hold’ service, or if there’s a signal and a sponsor wants a second opinion, we can provide an independent read to confirm the site results. Also, investors prefer to see independent read data rather than unblinded sites’ results”
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