The Evolving Role of Oncology Imaging Vendors for Clinical Trials.

Introduction

The oncology clinical trial landscape has seen a significant increase in investment in recent years. Global spending on cancer medicines is expected to reach a staggering $409 billion by the year 2028, fueled by an increase in cancer prevalence and milestone advancements in disease understanding. Oncology clinical trials are not only becoming exceedingly complex, but highly individualized.

Personalized medicine is a novel subset of cancer research which focuses on tailoring treatment and medications based on the specific tumor type, gene mutation, and genetic makeup of the cancer and the individual undergoing treatment. Each personalized medicine approach requires a distinct trial design, individualized protocols, and a unique trial infrastructure tailored to its specific mechanisms and patient population. Personalized therapies such as antibody-drug conjugates, tumor-infiltrating lymphocytes, and CAR-T cell therapies each require distinct design approaches, research considerations, and trial expertise.

Imaging vendors for clinical trials are becoming an integral aspect of oncology clinical trial success, not only advising on trial strategy, but facilitating the execution of imaging operations based on the specific personalized approach under investigation. This article will consider the evolving role of oncology imaging vendors for clinical trials.

High-stakes oncology research

The stakes in oncology research are inherently high, not only due to the severity and impact of cancer diagnosis around the world, but considering trial and therapeutic complexity, elevated operational costs, ethical considerations, and the extensive resource allocation required to develop global, multi-center, oncology clinical trials. While arguably being one of the most competitive areas of research, oncology drug development has one of the lowest clinical success rates of all major disease indications at approximately 3.4%, according to research published in Biostatistics.

Personalized and precision medicine has become an instrumental approach to contemporary cancer care, in which novel therapeutic interventions are developed based on the unique underlying mechanism and biology of the specific tumor type. While this has been a significant discovery, driving innovation and improving patient outcomes, it has also made oncology clinical trial design more complex. Oncology clinical trials now require individualized trial design, biomarker-driven patient selection, specialized imaging strategies, and highly coordinated global operations in order to succeed.

This article will go on to consider some specific therapeutic examples, and the evolving role of oncology imaging vendors for clinical trials.

Precision medicine examples and the challenges of solid tumor research

Antibody-Drug Conjugates (ADCs) represent a novel class of biopharmaceuticals which combine monoclonal antibodies with powerful chemotherapy drugs, joined together via engineered chemical linkers. This discovery allows for the targeted delivery of cytotoxic agents to the tumor site while minimizing off-target effects. While representing a huge step forward for oncology patient care, and achieving remarkable success both clinically and commercially, ADC development comes with its own unique set of clinical challenges. Assessment of treatment efficacy can be complex, as the mechanism of action of ADCs can lead to heterogeneous mixed tumor responses, which require centralized imaging reads, customized imaging protocols, and specialist radiologist training. ADCs have also been associated with a risk of pulmonary abnormalities, requiring advanced imaging modalities to monitor for ILD toxicity such as high-resolution computed tomography (HRCT), and a centralized independent joint events committee.

Tumor-Infiltrating Lymphocytes (TILs) are immune cells naturally involved in the body’s anti-tumor response, typically moving from the blood into a tumor. Tumor-infiltrating lymphocytes can recognize and kill cancer cells and have become the subject of much oncology research. TILs are removed from a patient’s tumor, multiplied in a lab, and then readministered to the patient to help boost the body’s natural tumor-specific immune response. While clinical development of TIL therapy has seen therapeutic advancements across multiple tumor types, including non-small cell lung cancer, cervical cancer, head and neck cancer, and ovarian cancer, TIL research continues to face considerable challenges in scalability, manufacturing complexity, and the need for robust biomarkers to predict response.

Volumetric assessments and immune-related response criteria are essential to accurately evaluate tumor response, and imaging readers must be trained to recognize and respond to atypical response patterns, which can be common in this type of research. Similarly, CAR-T Cell therapies, which involve the genetic engineering of a patient’s T cells, require complex neurotoxicity monitoring via advanced imaging modalities, and integration of imaging biomarkers for early signal detection.

The evolving role of oncology imaging vendors

Imaging vendors for clinical trials are quickly becoming an integral component of clinical trial success, particularly in the face of complex oncology clinical trial design and operational considerations. Oncological innovation has seen the development of immune therapies, molecular-targeted agents, gene therapies,      ADCs, radioligand therapies, and RNA-based therapies, giving patients not only hope, but improved clinical outcomes.

Imaging vendors are assisting sponsors in the development of these novel therapies, providing specialized imaging protocols, centralized and consistent image reads, 24/7 operational support, and regulatory-compliant data management in the face of both complex and challenging clinical trial design.

The imaging provider you choose can make or break your research. It is extremely important to make sure your clinical trial imaging vendor has the therapeutic expertise, scalability, and commitment to quality needed to drive the success of your highly personalized oncology clinical trial.

What to look for in an imaging partner?

Expertise

Choose an imaging vendor with a deep understanding of the oncology indications specific to your research. Therapeutic-specific experience, including ADCs, radioligand therapy, CAR-Ts, and TILs, enables your imaging provider to design tailored imaging protocols, anticipate and manage complex response patterns, and deliver high-quality, consistent data sets. An imaging provider with novel imaging modality experience can offer cutting-edge techniques, including advanced PET tracers, functional MRI, and molecular imaging, which will enable the development of deeper biological insight and assessment of treatment response.

Scale

The scalability of oncology research refers to the ability to expand research efforts in order to drive larger and more diverse data sets. However, scalability of clinical research requires a competitive, and global operational footprint. A scalable imaging infrastructure includes robust technological platforms, large global reader pools, and a global and connected site network of clinical experts and KOLs.

Choosing an imaging provider with a dynamic global infrastructure will bolster your trials’ success, enabling seamless coordination across multiple sites, supporting global data collection and analysis, and delivering generalizable results on a global scale; highly beneficial for regulatory approval.

Commitment to quality

Quality data is the backbone of any regulatory approval, without it, we would not have safe and effective treatments reaching real-world patients. Choosing an imaging provider who prioritizes quality processes will improve regulatory readiness. Through effective compliant image collection and handling, centralized read consistency and inter-reader reliability, you can ensure your trial meets the regulatory requirements needed to accelerate clinical development to market availability.

Read the white paper ‘De-Risking Medical Imaging in Solid Tumor Trials’: https://www.perceptive.com/news/de-risking-medical-imaging-in-solid-tumor-trials/

Imaging vendors are becoming strategic assets in the face of high stakes oncology research, their role evolving in the face of clinical trial complexity and ongoing innovation. An expert imaging provider can tailor image acquisition protocols based on therapeutic mechanism, provide custom training to ensure imaging protocol compliance, and enable operational insight with real-time feedback loops, dashboards, image QC controls, and proactive data flow monitoring.

Perceptive Imaging brings nearly 30 years of experience in clinical trial imaging support, with proven industry leadership in oncology research. A robust team of in-house clinicians and imaging scientists will assist the development of your clinical trial design, imaging acquisition, and analysis. Partnering with Perceptive will drive the success of your solid tumor treatment development program, ensuring operational excellence from imaging charter development through to endpoint analysis and regulatory submission.

Learn more about Perceptive Imaging Services today, or contact an imaging solutions specialist.

Resources

1. Grand View Research. Oncology Clinical Trials: Current Dynamics And Pipeline Outlook. https://www.grandviewresearch.com/market-trends/oncology-clinical-trials-current-dynamics-pipeline-outlook
2. Biostatistics. Estimation of clinical trial success rates and related parameters. https://academic.oup.com/biostatistics/article/20/2/273/4817524
3. Journal of Hematology & Oncology. Antibody–Drug Conjugates (ADCs): current and future biopharmaceuticals. https://jhoonline.biomedcentral.com/articles/10.1186/s13045-025-01704-3
4. National Cancer Institute. Tumor-infiltrating lymphocyte. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/tumor-infiltrating-lymphocyte
5. National Cancer Institute. CAR T Cells: Engineering Patients’ Immune Cells to Treat Their Cancers. https://www.cancer.gov/about-cancer/treatment/research/car-t-cells