QuIC-ConCePT, Quantitative Imaging in Cancer: Connecting Cellular Processes with Therapy, is an Innovative Medicines Initiative (IMI) funded project designed to qualify imaging biomarkers of tumor cell proliferation, apoptosis, and necrosis.
A major goal is to enable drug developers to incorporate these imaging biomarkers in Phase I clinical trials of investigational therapies and be confident that the imaging biomarkers are technically valid, that a measured change in the imaging biomarkers faithfully reflects the desired change in the underlying tumor pathology, and that the imaging biomarkers can be readily deployed in multiple cancer centers in a robust, consistent, ethical, and cost-effective way acceptable to the patients.
Imaging biomarkers of tumor cell proliferation and necrosis will be developed from 3′-deoxy-3′-[18F] fluorothymidine (FLT) positron emission tomography (PET) and apparent self-diffusion coefficient (ADC) of water protons measured by magnetic resonance imaging (MRI), respectively. Recognizing that the science around apoptosis tracers is less secure, studies will initially focus on the novel isatin-5 sulfonamide PET tracer [18F]ICMT-11 (ICMT-11), but the work plan allows additional or alternative apoptosis tracers to be utilized in later years.
A more exploratory objective of QuIC-ConCePT includes a portfolio of highly innovative approaches to devise, evaluate, and introduce imaging biomarkers of invasion and metastasis.
Overall, QuIC-ConCePT will be delivered using a creative and comprehensive portfolio of animal, human, image analysis, and regulatory work. The plan is to evaluate these imaging biomarkers, assess their reproducibility, effects of intervention, timing, dose-response, and imaging-histopathology correlation in animals and patients. Platforms for data acquisition, analysis, and dissemination will be standardized and integrated across the consortium in order to support this project.
The QuIC-ConCePT consortium comprises 25 partners: 14 academic, eight European Federation of Pharmaceutical Industries and Associations (EFPIA), and one Small and Medium Enterprise (SME). QuIC-ConCePT is coordinated by AstraZeneca and managed by the European Organisation for Research and Treatment of Cancer (EORTC).