Imaging Immunotherapy for Precision and Progress in Cancer Clinical Trials
Immunotherapy has transformed cancer treatment by harnessing the body’s natural defenses to target and destroy cancer cells. However, evaluating its effectiveness presents unique challenges. Imaging is crucial—not only for monitoring tumor response and detecting distinctive patterns like pseudoprogression, but also for identifying adverse events early. For immunotherapy clinical trials, advanced imaging techniques are essential for guiding decisions and improving patient outcomes.
The immune-oncology field has rapidly adopted new imaging technologies and evaluation criteria (irRC, irRECIST, iRECIST) to better capture immunotherapy’s complex effects, including distinguishing pseudoprogression from true progression. The iRECIST guidelines often supplement RECIST 1.1 for differentiating unconfirmed and confirmed disease progression. Advanced modalities like immunoPET utilize radiolabeled antibodies or fragments to target specific cancer biomarkers such as HER2, EGFR, PD-L1, and PSMA. This allows for more precise therapy selection and response monitoring, supporting personalized cancer care. Importantly, smaller antibody fragments improve imaging clarity and speed, though they present unique technical challenges.
At Imaging Endpoints, we strive to Connect Imaging to the Cure. We customize Imaging Review Charters and Manuals based on each clinical indication and experimental agent, guiding sponsors in defining study endpoints and supporting the advancement of new therapies. By leveraging both anatomical and functional imaging, our approach helps detect metabolic changes before anatomical or clinical response is seen, enabling early treatment decisions. ImmunoPET, using radiolabeled monoclonal antibodies such as 64Cu and 89Zr, offers a noninvasive way to visualize and quantify antibody drug pharmacokinetics and disease markers throughout the body. This method is applicable across several cancer types—including breast, lung, colorectal, and prostate — helping sponsors monitor response patterns and refine patient selection criteria. For example, 89Zr-trastuzumab PET can non-invasively assess HER2 expression in breast cancer, while anti-PD-1/PD-L1 tracers inform therapy selection in lung cancer. Standardized imaging protocols and advanced PET technology further ensure reliable data for complex clinical trials.
Recent studies show that combining immunotherapy with chemotherapy before surgery yields better outcomes than either approach alone. In lung cancer, this strategy often leads to cancer elimination by surgery and lower relapse rates. New targeted agents like taletrectinib for ROS1-positive non-small cell lung cancer are also showing promise in clinical trials.
With a flawless inspection record and an impressive 95% marketing authorization success rate in all supported clinical trials, Imaging Endpoints leads in developing imaging solutions for immunotherapy trials. To connect with our experienced medical and scientific professionals and explore how our tailored imaging solutions can support your immunotherapy clinical trials.

