Chemotherapy dose monitoring using a wearable, microdialysis-based assay system

DESCRIPTION (provided by applicant): Invivomon, Inc. is a company developing in vivo monitoring technologies that will track 5-fluorouracil (5-FU) chemotherapy levels in a patient's blood using an intravenous (IV) line. Treatment failure and toxicity are tragic and all too familiar outcomes of cancer chemotherapy. Strong evidence exists that dose individualization by therapeutic drug monitoring (TDM) can decrease these problems. The current perception of practitioners is that providing multiple blood levels and dosage adjustments, although theoretically desirable, is too cumbersome to be practical and too expensive to be cost effective. Invivomon is developing a wearable, minimally invasive system for blood level monitoring of 5-FU. This system will couple microdialysis blood sampling to a miniaturized immunoassay for 5-FU and also with an embedded control system (small computer). The embedded system will manage the 5-FU assay, monitor system performance, provide fail-safe features, and correct microdialysis sampling errors. The long term goal of this project is to develop a programmable 'Smart IV' that can be used in any patient with an IV, in both inpatient and outpatient settings. This technology will allow precise dose individualization i.e. personalized medicine to become a reality. This will proceed with the development of a pharmacokinetic population model for 5-FU which can ultimately be used for clinical decision support to optimize 5-FU dosing for each patient. The Phase I hypothesis is that a wearable, intravenous microdialysis system with an in-line turbidimetric immunoassay can accurately track 5-FU drug blood levels in vitro. Specific aims for Phase I include: 1) To develop a miniature (3 x5 x2 ) analyzer that can that can be coupled to microdialysis to quantitate 5-FU blood concentrations based on an off-the-shelf, FDA-approved turbidimetric immunoassay, and 2) To develop a wearable, microdialysis system capable of accurately tracking 5-FU concentrations over time. Phase I will enable the fabrication of a prototype that demonstrates frequent (approx. every 20 minutes) 5-FU blood level measurements and portability for use with ambulatory patients. It will also demonstrate suitability for monitoring a 46-hour 5-FU infusion that is part of colon cancer treatment. A small clinical study is planned in Phase II with patients receiving the mFOLFOX6 regimen for colon cancer (Leucovorin, 5-FU, and Oxiplatin) at the University of Pittsburgh Cancer Institute. This pilot clinical study will validate device performance under real world conditions. In the future newer high-cost drugs, more complex dosing regimens, and chronic care patients on multiple drugs will continue to expand the TDM market, which is expected to be 1.1 B worldwide by 2011. PUBLIC HEALTH RELEVANCE: Individual patients react very differently to the same chemotherapy dose due to differences in metabolism. Invivomon Inc. is developing a Smart IV that will measure chemotherapy drug levels in the blood during chemotherapy. This will allow doctors to prescribe the precise dose that is best for each patient.