Immune-Directed Molecular Imaging Biomarkers.

Imaging has played a critical role in the management of patients with cancer. Novel therapies are emerging rapidly; however, they are effective only in some patients. With the advent of new targeted therapeutics and immunotherapy, the limitations of conventional imaging methods are becoming more evident. FDG-PET imaging is restricted to the optimal assessment of immune therapies. There is a critical unmet need for pharmacodynamic and prognostic imaging biomarkers. Radiolabeled antibodies or small molecules can allow for specific assessment of targets in expression and concentration. Several such imaging agents have been under preclinical development. Early human studies with radiolabeled monoclonal antibodies or small molecules targeted to the epidermal growth factor receptor pathway have shown potential; targeted imaging of CA19.9 and CA-IX and are being further explored. Immune-directed imaging agents are highly desirable as biomarkers and preliminary studies with radiolabeled antibodies targeting immune mechanisms appear promising. While novel agents are being developed, larger well-designed studies are needed to validate the role of these agents as biomarkers in the clinical management of patients.