Nanoparticle-Enhanced molecular Fluorescence-Endoscopy for detection of colon cancer (NanoEFEct)

It is the aim of this Project to develop, design and realize a multidimensional data evaluation system optimized for step-by-step approach for accompanying and facilitating the development of nanoparticles as an in-vivo diagnostic tool for the detection of precancerous and early cancerous lesions in the colon via fluoroscopy. Each nanoparticle (NP) will contain (1) the nanoparticle itself based on albumin, gold or biodegradable polymers, (2) the EpCAM antibody and (3) a licensed fluorochrome such as IndoCyanin Green (ICG). Regulatory guidance will already be applied to choose the right starting materials like the use of certain versions of the tagging and targeting groups. The project will collect, evaluate and cross-check all data, like data on physicochemical characteristics, targeting properties of EpCAM-targeted NPs in vitro, fluorescence optical properties of fluorophore-tagged NPs in vitro, NP stability in body fluids at body temperature in vitro, NP stability in conditions relevant to shelf life and transport in vitro, cytotoxicological characteristics of NPs. Based on these data, it will be decided together with the international partners which NPs can proceed to the next step or need further improvement. The Project will apply a similar strategy for in vivo testing on human biopsates and animal models for testing the applicability in a mouse colonoscopy model. During the Project`s lifetime, the Project will be continuously evaluated from a regulatory perspective, and new regulatory guidance will be reviewed for applicability; we will actively foster communication with and seek advice from European and National Regulatory Authorities. Contacts with regulators will be largely informal, but the Project also aims to apply for Scientific Advice at the National Regulatory Authority in Austria (AGES) and to implement the advice received in order to meet the goal to provide Nanoparticle-enhanced fluoro- chromo-endoscopic molecular imaging systems adapted for routine clinical applications, and conforming to safety and efficacy criteria to find best suitable candidate(s) for further development as an in-vivo diagnostic tool and enabling the start of clinical trials.

No additional funding sources recorded.