QuIC-ConCePT aims to qualify three specific imaging biomarkers of tumor cell proliferation, apoptosis, and necrosis, [18F]fluorothymidine (FLT) positron emission tomography (PET), apparent self-diffusion coefficient (ADC) of water protons measured by magnetic resonance imaging (MRI), and isatin-5 sulfonamide PET tracer [18F]ICMT-11 (ICMT-11), to allow the drug developer to demonstrate reliably the modulation of these pathologic processes in tumors in patients in future trials.
A second aim (10% of the investment, WP6) is to develop and validate an IB based on a human antibody targeting metalloproteinase 2 (MMP2) on preclinical models, and to validate an approach quantifying invasiveness and early response by quantifying image features on CT and PET scans on preclinical and clinical models, a so-called “radiomics” approach.
Our vision for FLT, ADC, and ICMT-11 is that by April 2016, drug developers can incorporate these imaging biomarkers for decision-making in Phase I trials of investigational therapies, confident that the imaging biomarkers are technically valid, that a measured change in the imaging biomarker 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 that is acceptable to the cancer patients volunteering for our trials.
Each imaging biomarker is under the scientific supervision of an Imaging Biomarker Champion, and each work package is under the supervision of a work package leader. Project managers work closely with the Work Package Leaders, who are accountable for the management of deliverables and resources in their respective area.