Question ID: WS-13
Submitted by: David Mankoff
January 26, 2011
Question: How can we use molecular imaging to accelerate the process of drug development and testing? Background: Molecular imaging can quantify the in vivo biology of cancer, and monitor its response to treatment, and can provide a useful tool for accelerating translation of new therapeutics into clinical trials and clinical practice. Imaging may be particularly helpful for targeted drug therapy, by verifying that the target is present in all disease sites and by measuring the effect of the drug on the target and on the cancer. While the ability of molecular imaging to facilitate cancer drug testing and clinical trials has been recognized for some time (Kelloff,2005), there has been slow progress in harnessing the full power of molecular imaging for clinical cancer trials. Feasibility: The limited access of investigators to novel molecular imaging probes has hampered widespread use. However, over the past few years, work by individual centers, the NCI Cancer Imaging Program, and NCI research grants has resulted in a readily available commercial supply of many probes. NCI-held INDs for PET probes have contributed to their wider use in clinical trials, and provided standardized imaging protocols and data analysis. Early studies have demonstrated the ability to implement molecular imaging and obtain consistent and reproducible results in multi-center trials. The remaining hurdle is providing an incentive to use molecular imaging in early drug trials, mostly likely by encouraging private-public partnerships between pharma (sponsors of early drug trials) and academia and cooperative groups (experts in molecular imaging). At the same time, it is important to continue development and phase I validation of new imaging probes. Implications of Success: The use of molecular imaging to guide drug testing should increase the efficiency of drug development and accelerate the clinical implementation of treatments destined to be useful. In many cases, these same imaging tests can be used to guide the selection of targeted cancer therapy in the clinic, directing clinicians towards the drug most likely to be effective, and avoiding drugs unlikely to have an impact on the tumor and the patient’s survival. 1. Kelloff GJ, Krohn KA, Larson SM, et al. The progress and promise of molecular imaging probes in oncologic drug development. Clin Cancer Res. Nov 15 2005;11(22):7967-7985.
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